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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
October 3, 2007
07-40
___________________________________
PRODUCT
Dolci Cioccolati, Bella Cucina Artful Food, Death by Chocolate Cookies, Net
Wt. 6 oz – 170G; UPC code 1919300020. Product is packed in a clear plastic
pouch surrounded by rigid paper labeling. The ingredient statement is located
on the bottom panel which should have a separate sticker in the same vicinity
which states, “This Product Contains Walnuts”, Recall # F-481-7
CODE
All packages manufactured between June 14, 2007 to July 5, 2007 which do not
bear the sticker “This Product Contains Walnuts”.
RECALLING FIRM/MANUFACTURER
Bella Cucina Artful Food, Atlanta, GA, by telephone on/about August 22, 2007
and letter and press release on August 28, 2007. Firm initiated recall is ongoing.
REASON
Cookies contain undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
36 cases (12/6 oz. packages per case)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Pulparindo Hot and Salted Tamarind Pulp Candy; Nt. Wt. 0.49 oz.; Dulce de
Tamarindo; Product of Mexico 20 x 0.49 oz. pieces per 10 oz. box; 24 x 10
oz. boxes per case. 0.49 oz. piece – UPC 725226066660; 10 oz. box )20x0.49
oz. pieces) UPC 72522600020, Recall # F-536-7
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: La Flor Mexicana Spices, Inc., Passaic, NJ, by telephone on
September 5, 2007 and by letter dated August 30, 2007.
Manufacturer: Chupaletas S.A. de C.V., Guadalajara, Jalisco, Mexico. Firm initiated
recall is ongoing.
REASON
New York State Department of Agriculture and Markets tested the product and
found up to 0.249 ppm lead.
VOLUME OF PRODUCT IN COMMERCE
Approximately 290 boxes (20 x 0.49 oz. pieces per box)
DISTRIBUTION
NC, NJ, NY and PA
___________________________________
PRODUCT
Aoun Custard powder mix; 500 gram paper bag in paper box nt. Wt. 500 grms,
17 ½ oz. Made in Lebanon, Recall # F-480-7
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baroody Imports, Inc., Clifton, NJ, by visit beginning on July
18, 2007.
Manufacturer: Aoun Food Company-Aoun S.A.R.L., Mazraat Yachouh, Lebanon. Firm
initiated recall is complete.
REASON
Product contains color Ponceau 4R (E124), which is unapproved for use in the
United States.
VOLUME OF PRODUCT IN COMMERCE
38 cases (24 units per case)
DISTRIBUTION
NY and NJ
___________________________________
PRODUCT
a) Panocaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP)
Rx Only, 100 CAPSULES, NDC 51991-408-01, Recall # D-978-2007;
b) Ultracaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP),
100 CAPSULES, Rx Only, NDC 51991-409-01, Recall # D-979-2007;
c) Palcaps 10 Capsules (Pancrelipase Delayed Release Capsules, USP)
Rx Only 100 CAPSULES, NDC 51991-410-01, Recall # D-980-2007
CODE
a) PCC8eS001;
b) PCC9eS001 (expires Apr 08), PCC9eS002 (expires Aug 08);
c) PCC10eS001 (expires Feb 08), PCC10eS002 (expires Jul 08),
PCC10eS003 (expires Sep 08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carlsbad Technology Inc., Carlsbad, CA, by telephone on
April 18, 2007.
Manufacturer: Yung Shin Pharmaceutical Industry, Ltd., Tachia, Taiwan, Republic
Of China. Firm initiated recall is ongoing.
REASON
Presence of Undeclared Color Additive; product capsule shells contain undeclared
FD&C Yellow #5 and Discrepancies between labeled inactive ingredients in
the package inserts and the inactive ingredients contained in the products;
Some product capsule shells also contain undeclared color additive FD&C
Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
30,536 bottles
DISTRIBUTION
TN
___________________________________
PRODUCT
Octreotide Acetate Injection, 500 mcg/mL (0.5 mg/mL); an Rx subcutaneous injection
long-acting octapeptide with pharmacologic actions mimicking those of the natural
hormone somatostatin; 1 mL single dose vial, 10 vials per carton; product number
370701, NDC 63323-377-01, Recall # D-975-2007
CODE
Lot number 202500, expiration date 6/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL, by letters dated
August 2, 2007.
Manufacturer: Abraxis Pharmaceutical Products, Melrose Park, IL. Firm
initiated recall is ongoing.
REASON
There is an error on the vial label that incorrectly indicates the product
concentration is 0.05 mg/mL octreotide acetate when the actual concentration
is 0.5 mg/mL.
VOLUME OF PRODUCT IN COMMERCE
1,490 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Terbinafine Hydrochloride Tablets, USP, equivalent to 250 mg base, Rx only,
500 Tablets, NDC 24658-180-05, Recall # D-981-2007
CODE
Lot I0707102 (Exp. 06/09)
RECALLING FIRM/MANUFACTURER
InvaGen Pharmaceuticals, Inc., Hauppauge, NY, by telephone on August 27, 2007
and by letter dated August 29, 2007. Firm initiated recall is ongoing.
REASON
Labeling: Terbinafine Hydrochloride Tablets, 250 mg, 500 count bottles, Lot
I0707102, were incorrectly labeled as Terbinafine Hydrochloride Tablets, USP
VOLUME OF PRODUCT IN COMMERCE
343 bottles (500 tablets per bottle)
DISTRIBUTION
KY
___________________________________
PRODUCT
EstroGel® 0.06% (estradiol gel), 24 gram multiple dose pump packaged in
papercard carton labeled in part ***Physician Sample***For Topical Use Only***Metered-dose
pump capable of delivering fourteen 1.25 gram doses, Recall # D-982-2007
CODE
Lot 3136 Expiration September 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ascend Therapeutics, Inc., Herndon, VA, by letter on August
20, 2007.
Manufacturer: Laboratories Besins Iscovesco, Montrouge Cedex, France. Firm
initiated recall is ongoing.
REASON
Mislabeled. Product labeled with incorrect expiration date (September 2009
instead of September 2007)
VOLUME OF PRODUCT IN COMMERCE
27,351 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1388-07
CODE
Unit: 029KC67762
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlanta, Norfolk, VA, by letters and electronic
mail on June 22 and 30 and August 15, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA and CA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1409-07;
b) Platelets, Recall # B-1410-07
CODE
027GS07188
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic mail on
January 31, 2007. and/or by letter dated February 1, 2007. Firm initiated recall
is complete.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, WV and CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1449-07
CODE
Units: 019FZ31873 and 019LV36559
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by
letter dated December 11, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets, Recall # B-1475-07
CODE
Unit: 1124187
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on December 30, 2003.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin prior
to the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1476-07
CODE
Units: 5822417, 5823702, 5823715, 5822420, 5823717, 5823735, 5823739, 5823716,
5823670, 5823743, 5822423, 5822421, 5823482, 5821508, 5822276, 5796481, 5790966,
5796876, 5824765, 5823573, 5790968, 5823567, 5823603, 5824382, 5822288, 5796797,
5796440, 5823232, 5824364, 5824432, 5824367, 5824371, 5824435, 5824404, 5822304,
5822410, 5822387, 5822418, 5823660, 5822422, 5823704, 5823740, 5822418, 5823595,
5823582, 5822419 (split unit), 5790985, 5823289, and 5791486
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone or facsimile on March
3, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been stored under unacceptable storage conditions
were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
LA and AZ
___________________________________
PRODUCT
Platelets, Recall # B-1479-07
CODE
Unit: 1124767
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated December 23, 2003.
Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receipt of information regarding post-donation
illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1499-07
CODE
Unit: 19GG76493, split product, two units
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by
letter dated December 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected without complete documentation of the apheresis process,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets, Recall # B-1539-07
CODE
Unit: 3938837
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on February 11, 2007. Firm initiated
recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin Prior
to the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1540-07;
b) Red Blood Cells, Recall # B-1541-07
CODE
a) Unit: 4057297;
b) Units: 4032050 and 4058425
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone and facsimile beginning
January 25, 2007. Firm initiated recall is complete.
REASON
Blood products, associated with units that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC and SC
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1542-07
CODE
Unit: 0240885
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone and letter dated January
17, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a Red Blood Cell unit that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1543-07
CODE
Unit: 71X348661
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January
10, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Platelets that contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets, Recall # B-1544-07
CODE
Unit: 71Q706365
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on October
10, 2005. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Plataelets Pheresis, Leukocytes Reduced, Recall # B-1545-07
CODE
Unit: 71X140825
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on October
3, 2005. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Ampilink Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS
Amplicor HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS
AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen
HIV-1 Test, version 1.5], Recall # B-1554-07
CODE
Catalog number 03309401018; working probe suspension/SM PS1-SM4; Working substrate
SB3-SB; Catalog number 03155935018; working Probe Suspension/IM PS1-IM4; Working
substrate SB3-SB; Catalog number 03599779190 Working Substrate SB3-SB; Catalog
number 03302563018, Working Substrate SB3-SB; Catalog number 03322114018, Working
Substrate SB3-SB.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters
on May 21, 2007.
Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated
recall is ongoing.
REASON
For select COBAS AMPLICOR tests run on the COBAS AMPLILINK software, a discrepancy
has been identified between the onboard working reagent stability information
reported by AMPLILINK Software (versions 1.1, 1.3, 1.4, and 2.41) and the stability
information provided in the test kit package inserts/method manual.
VOLUME OF PRODUCT IN COMMERCE
5,806 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Software used by Blood Collection Centers and Blood Banks for donor screening.
Product Title: Blood Bank Control System Funtion/File/Callable: 087 Title: Donor
Room Management Release: 5.0, 5.1, 5.2, 5.2.1, 5.2.2, and 5.3 (POD0001) DPP #:
4012E, Recall # B-1556-07
CODE
Product Title: Blood Bank Control System Funtion/File/Callable: 087 Title: Donor
Room Management Release: 5.0, 5.1, 5.2, 5.2.1, 5.2.2, and 5.3 (POD0001) DPP #:
4012E
RECALLING FIRM/MANUFACTURER
Blood Bank Computer Systems, Inc., Auburn, WA, by e-mail on April 26, 2007 and
by telephone on April 27, 2007. Firm initiated recall is ongoing.
REASON
Software, containing a glitch or defect related to donor deferral, was distributed.
VOLUME OF PRODUCT IN COMMERCE
193 CD’s
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Misys Encompass Versions 2.2.1, 2.3 and 2.4, Recall # B-1557-07
CODE
Versions 2.2.1, 2.3 and 2.4
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on
April 16, 2007. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
PA, NJ, OH, GA, AL, NY, OK, IL, MA, NM
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1581-07
CODE
Unit: 314872051 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November
10, 2006.
Manufacturer: Blood Systems Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum requirement for total hemoglobin,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS and AL
___________________________________
PRODUCT
a) Level 1 Normothermic IV Administration Sets, Disposable Sets: (D-60HL / DI-60HL
Maximum normothermic flow rate: 500 mL/min; Disposable D-50
/ DI-50 M
aximum normothermic flow rate: 300 mL/min; D-100 / DI-100
Maximum
normothermic flow rate: 800 mL/min; D-300 / DI-300 Maximum
normothermic
flow rate: 1000 mL/min; D-70 Maximum Flow Rate 525ml/min,
Recall # B-1583-07;
b) Level 1 Normothermic Irrigating Set IR-500, IR-600 & IRI 600 IRI 600B,
IR-700, IR-40, Recall # B-1584-07
CODE
a) and b) All lots prior to the Expiration Date of July 2011 or earlier and not
labeled
with "Helium tested"
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter dated July 25, 2007. Firm initiated
recall is ongoing.
REASON
Heat exchanger may leak in the inner lumen contaminating the blood/solutions
being infused or the recirculating solution.
VOLUME OF PRODUCT IN COMMERCE
900,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Level 1 H-1200 Fast Flow Fluid Warmer equipped with H-31B Air
Detector/Clamp 510K=BK020043, Recall # B-1585-07;
b) Level 1 H-331B Air Detector accessory, Recall # B-1586-07
CODE
Units with a plastic door latch are affected.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter on February 22, 207. Firm initiated
recall is ongoing.
REASON
Fluid Warmers, if the door latch is broken or bent, the Air Detector door will
not close properly and the presence of air is detected and an audible and visual
alarm sounds.
VOLUME OF PRODUCT IN COMMERCE
1,388 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1587-07
CODE
Unit: 4360136
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on May 15, 2006. Firm
initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ and SC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1594-07
CODE
Unit: 307744683
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 22,
2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1595-07
CODE
Unit: 307744734
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 8,
2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was
not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
___________________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1596-07;
b) Platelets Leukocytes Reduced, Recall B-1597-07;
c) Frozen Plasma, Recall # B-1598-07;
d) Recovered plasma, Recall # B-1599-07
CODE
a) Units: 17FG29694, 17FG33256, 17FG36181, 17FG39281, 17FG45007,
17FG49548, 17KC58352.;
b) Units: 17FG29694, 17FG33256, 17FG39281, 17FG45007, 17FG49548;
c) Units: 17FG33256, 17FG45007;
d) Units: 17FG29694, 17FG36181, 17FG39281, 17FG49548, 17KC58352
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by email,
facsimile and letter on October 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
MA, MN, VA, WI and DC
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1601-07;
b) Cryoprecipitated AHF, Recall B-1602-07;
c) Plasma Cryoprecipitate Reduced, Recall # B-1603-07
CODE
a) Units: J30241 and J30005;
b) and c) Unit: J30241;
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letters dated July 28, 2006 and
August 4, 2006 and by e-mail on July 28, 2006 and August 7, 2006. Firm initiated
recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 components
DISTRIBUTION
VA and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1605-07
CODE
Unit: 4340416
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on August 8, 2005.
Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors
for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC and CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1606-07
CODE
Unit: 4343919
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on February 16, 2005.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1607-07
CODE
Unit: 71Q584413
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile dated
October 25, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated
blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
________________________________
PRODUCT
Recovered Plasma, Recall # B-1389-07
CODE
Unit: 029KC67762
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlanta, Norfolk, VA, by letters and electronic
mail on June 22 and 30 and August 15, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA and CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1411-07
CODE
027GS07188
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone or electronic mail on
January 31, 2007. and/or by letter dated February 1, 2007. Firm initiated recall
is complete.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, WV and CA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1461-07
CODE
Units: 1717623, 6149458, 6149525, 6149570, 6149613, 1717619, 1717832, 1717838,
1717839, 1717844, 1717853, 1805099, 2339808, 2339902, 3233362, 2339805, 1717388,
1717392, 1717393, 2339139, 1407292, 2339278, 6148601, 6148609, 1804909, 2339276,
1804953, 3232837, 3232839, 6148375, 6148599, 6148608, 6148611, 6148613, 6148614,
6148615, 1717723, 3233105, 6149199, 1664232, 2339382, 2339401, 2339403
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on
January 13, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperatures during
storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
TX and AZ
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1477-07;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-1478-07
CODE
a) Unit: 1113285;
b) Units: 1113288 (double collection) and 1113290
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on December 5, 2003 and/or
letter dated January 2, 2004. Firm initiated recall is complete.
REASON
Blood product, which may have been stored under unacceptable storage conditions,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1500-07
CODE
Unit: 1382182538
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by
telephone on April 5, 2005 and by letter dated April 6, 2005. Firm initiated
recall is complete.
REASON
Blood product, lacking assurance being maintained at an acceptable temperature
during shipping, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Pneumovax 23 (Pneumococcal Vaccine Polyvalent) single Dose Vial. 25mcg/ml,
10 vials per pack. NDC number 0006-4943-00; Pneumovax 23 (Pneumococcal Vaccine
Polyvalent) 25mcg/ml, multi dose vial. NDC number 0006-4739-00, Recall # B-1555-07
CODE
Lot number 1004F expiration 12/8/08; Lot number 0988F expiration 11/3/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen, Chesterbrook, PA, by telephone on February
28, 2007 and by letter on March 2, 2997.
Manufacturer: Merck and Co., Inc., West Point, PA. Firm initiated recall is
complete.
REASON
Vaccines, lacking assurance of proper temperatures during transit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
474 vials
DISTRIBUTION
CT, MA, ME, NH, NY, and RI
___________________________________
PRODUCT
Ortho Ficin Panel System Resolve Panel C A qualitative test for the identification
of unexpected blood group antibodies. Untreated For in Vitro Diagnostic Use
Package contains: Eleven 3 ml. vials red blood cells One 2 ml. vial Reagent
Red Blood Cell Diluent. Product code 719410 (US), Product code 6901867 (ex-US),
Recall # B-1558-07
CODE
Lot # RC329
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, NJ, by letters on June 14, 2007.
Firm initiated recall is ongoing.
REASON
Resolve Panel C, demonstrating unexpected reactivity with untreated Cell 16,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
393 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Recombivax HB (Hepatitis B Vaccine [recombinant]) 40mcg/ml, single dose
vials.
NDC number 0006-4992-00; Recombivax HB Adult Formulation
(Hepatitis B
Vaccine [recombinant]) 10mcg/ml, 10 vials per pack. NDC
number 0006-4995-41;
Recombivax HB Pediatric/Adolescent (Hepatitis B Vaccine
[recombinant])
5mcg/0.5ml, 10 vials per pack. NDC number 0006-4891-00,
Recall # B-1576-07;
b) VAQTA (Hepatitis A Vaccine [inactivated]) 50mcg/ml (Adult), single dose
vials,
10 vials per pack. NDC number 0006-4841-41, Recall # B-1577-07;
c) Pedvax HIB (Haemophilus b Conjugate Vaccine [Meningococcal Protein
Conjugate]) 7.5mcg HIB/125mcg Neisseria Meningitidis/225mcg
aluminum
per 0.5ml, 0.5 ml single dose vials, 10 vials per pack.
NDC number 0006-4897-00,
Recall # B-1578-07;
d) COMVAX (Haemophilus b conjugate[meningococcal protein conjugate] and
Hepatitis B [recombinant] Vaccine) 7.5mcg HIB/125mcg Neisseria
Meningitidis/
5mcg HBsAG per 0.5ml, 0.5 ml single dose vials, 10 vials
per pack. NDC number
0006-4898-00, Recall # 1579-07
CODE
a) Lot number 0650F expiration 11/28/08,
Lot number 1160F expiration 7/6/09,
Lot number 1246F expiration 2/3/09;
b) Lot number 1278F expiration 10/12/09;
c) Lot number 1272F expiration 4/13/09;
d) Lot number 1158F expiration 4/4/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: AmeriSource Bergen, Chesterbrook, PA, by telephone on February
28, 2007 and by letter on March 2, 2007.
Manufacturer: Merck and Co., Inc., West Point, PA. Firm initiated recall is
complete.
REASON
Vaccines, lacking assurance of appropriate storage temperatures during transit,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
578 vials
DISTRIBUTION
CT, MA, NH, NY, and RI
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1582-07
CODE
Unit: 9064530 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on April 15, 2007 and
by letter dated April 16, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Diptheroid bacilli,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1588-07
CODE
Unit: 9052874
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on January 20, 2006.
Firm initiated recall is complete.
REASON
Blood product, which reached an unacceptable temperature during shipment, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1589-07
CODE
Unit: 107919113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 24,
2006.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is
complete.
REASON
Blood product, which did not have written documentation of the temperature
at the time of receipt, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1592-07
CODE
Units: 17GM50664, 17GM50665, 17KC85092, 17KC85125, 17GM50662, 17KE08664, 17KE08665,
17KE08669, 17KE08671, 17KE08656, 17KE08657, 17KE08663, 17KE08670, 17KE08672,
17KE08655, 17KE08658, 17KE08659, 17KE08660, 17KE08661, 17GR37518, 17KM54938,
17KT86784, 17KV49187, 17KZ51923
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, Saint Paul, MN, by electronic
notification on February 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during storage,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-1600-07
CODE
Unit: 71R485316
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL., by fax on March
14, 2006. Firm initiated recall is complete.
REASON
Blood product, possibly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_____________________________________
PRODUCT
Recovered Plasma, Recall # B-1604-07
CODE
Unit: J30005
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letters dated July 28, 2006
and August 4, 2006 and by e-mail on July 28, 2006 and August 7, 2006. Firm
initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 component
DISTRIBUTION
VA and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1608-07
CODE
Unit: 71R64066X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on March
2, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated
blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System,
Recall # Z-1238-2007
CODE
Version 1.07 of the EM2400 Operating Software.
RECALLING FIRM/MANUFACTURER
Baxa Corporation, Englewood, CO, by telephone and letter on June 27, 2007.
Firm initiated recall is ongoing.
REASON
A software defect could allow up to 50mL of extra volume being added to a TPN
(Total Parenteral Nutrition) solution.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
CA, CO, FL, DY, MI, NY, OH, OR, and TX
___________________________________
PRODUCT
a) Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL,
Models # 4535 679 71891, #4535 679 75681, #4535 679 75691.
Precedence,
Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A.
PET/CT
Computed tomography systems, Recall # Z-0013-2007;
b) Brilliance (a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice,
Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670
78851. Brilliance CT
16 Power, Model #4535 670 23331. Brilliance CT 40 Slice
Model #4550 110 04011.
Brilliance CT Big Bore, Model #4535 670 88051. Computed
tomography systems.
Recall # Z-0014-2007
CODE
a) Serial #s: 4034-4100, 4102, 4103, 1041;
b) Serial #s: 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118, 60006; 9145,
9036,
9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150, 7022
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letters on November
3, 2006. Firm initiated recall is ongoing.
REASON
A potential anomaly was identified on the CT subsystem, which could result
in the radiation dose being different than the calculated dose reported to
the operator.
VOLUME OF PRODUCT IN COMMERCE
90 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Pyxis Anesthesia System 3500, Model 3500, Recall # Z-0555-2007
CODE
All serial numbers of the Pyxis Anesthesia Station
RECALLING FIRM/MANUFACTURER
Cardinal Health 301 LLC DBA Cardinal Health Pyxis Products, San Diego, CA,
by telephone and letter beginning on August 13, 2007. Firm initiated recall
is ongoing.
REASON
System lock up; mini-drawers -under certain circumstances during use, are not
accessible, delaying the user from accessing critical medications.
VOLUME OF PRODUCT IN COMMERCE
369 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) OEC 9900 Elite image-intensified fluoroscopic x-ray system, Recall # Z-0676-2007;
b) OEC 9800 image-intensified fluoroscopic x-ray system, Recall # Z-0677-2007;
c) OEC 8800 image-intensified fluoroscopic x-ray system, Recall # Z-0678-2007;
d) OEC 9900 Elite MD Motorized C-Arm System, image-intensified
fluoroscopic x-ray system, Recall # Z-0679-2007;
e) OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system,
Recall # Z-0680-2007;
f) OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic
x-ray system, Recall # Z-0681-2007;
g) OEC 9800 Plus (Flourotrak) Image-intensified fluoroscopic x-ray system,
Recall # Z-0682-2007;
h) OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system,
Recall # Z-0683-2007
CODE
a) Serial Numbers: E2-0019, E2-0028, E2-0064, E2-0142, E2-0156, E2-0170, E2-0180,
E2-0213, E9-0008, E9-0040-G, E9-0103, E9-0029, ES-0060,
ES-0088, ES-0096,
ES-0099, E9-0150, E9-0152, E9-0158;
b) Serial Numbers: 429 units within the range 8S-0007 thru 8S-7163,
455 units within the range 89-0014 thru 89-3520,
659 units within the range 82-0010 thru 82-7138;
c) Serial Numbers: FIB-0020, FIB-0025, FIB-0038, FIB-0050, FIB-0065, 2799PU5,
2832PU4, 3380PU3, 3589PU9, 4037PU8, 4816PU5, 4842PU1, 4860PU3,
5190PU4, 5204PU3, 5210PU0, 5270PU6;
d) Serial Numbers: E2-7075-MH, ES-0029-CH, ES-0046-CH, ES-0066-CH, ES-0131-H;
e) Serial numbers: 89-1579-N, 89-2529-N, 82-2160-N, 8S-1932-N, 8S-2226-N;
f) Serial numbers: 82-7001-MH, 82-7004-MH, 82-7006-MH, 82-7009-MH, 82-7024-MH,
82-7034-MH, 82-7077-MH, 82-7086-MH, 82-7096-MH, 82-7098-MH,
82-7105-MH,
82-7110-MH, 82-7139-MH, 82-2061-C, 82-1094-C, 82-0619-M,
89-0483-C, 8S-7031-MH,
8S-7035-MH-RC, 8S-7047-MH, 8S-7075-CMH, 8S-7127-MH, 8S-7145-MH,
8S-7164-CMH,
8S-2791-C, 8S-2518-C, 8S-2519-C, 8S-2046-C, 8S-2054-C, 8S-1911-C,
8S-1772-C, 8S-1632-C,
8S-1490-C, 8S-1449-C, 8S-1224-C-RC, 8S-1212-C, 8S-1069-C,
8S-1065-C, 8S-1013-C,
8S-0849-C, 8S-0793-C, 8S-0790-C, 8S-0754-C, 8S-0744-C, 8S-0721-C,
8S-0717-C,
8S-0708-C, 8S-0678-C, 8S-0615-C, 8S-0559-C, 8S-0521-C, 8S-0510-C-RC,
8S-0421-C,
8S-0413-C, 8S-0405-C, 8S-0348-C-RC, 8S-0300-C, 8S-0192-C,
8S-0143-C, 8S-0144-C,
8S-0148-C, 8S-0140-C, 8S-0141-C, 8S-0093-C, 8S-0055-C, 8S-0011-C,
8S-0014-C,
8S-0016-C, 8S-0005-C, 8S-0006-C-RC;
g) Serial number 8S-2339-N;
h) Serial # ES-0152
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on March 1, 2007.
Firm initiated recall is ongoing.
REASON
During routine service, primary and/or secondary collimators may not have been
properly reinstalled.
VOLUME OF PRODUCT IN COMMERCE
1,661 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT
a) Practix 33 Mobile X-ray systems. The systems are used in general purpose
diagnostic imaging,
and are specifically used as mobile X-ray systems for bedside
radiological examinations,
Recall # Z-0762-2007;
b) Practix 160 Mobile X-ray systems. The systems are used in general purpose
diagnostic imaging,
and are specifically used as mobile X-ray systems for bedside
radiological examinations,
Recall # Z-0763-2007
c) Practix 300 Mobile X-ray systems. The systems are used in general purpose
diagnostic imaging,
and are specifically used as mobile X-ray systems for bedside
radiological examinations,
Recall # Z-0764-2007
CODE
a) Serial Numbers: P5-546; P5-370; P5-547; P5-529; P5-371; P5-426; PS-686;
P5-727,
and P5-548;
b) Serial Numbers P3-449 and P3-443;
c) Serial numbers 4561206, 6561652, 6561768, 6561732, 6561728, 6561730,
6561767, 355142, and 06561731
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters
starting April 3, 2007 through April 9, 2007. Firm initiated recall is ongoing.
REASON
X-ray systems lack product report certification demonstrating compliance, and
were illegally introduced into the United States commerce.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
PR
___________________________________
PRODUCT
a) Philips Bucky Diagnost X-Ray System, Recall # Z-0907-2007;
b) Philips Digital Diagnost X-Ray system, Recall # Z-0908-2007;
c) Philips Easy Diagnost X-Ray System, Recall # Z-0909-2007;
d) Philips Easy Diagnost Eleva, Recall # Z-0910-2007;
e) Philips Omni Diagnost Eleva, Recall # Z-0911-2007;
f) Philips Multi Diagnost Eleva, Recall # Z-0912-2007
CODE
a) Site numbers 5024, 5175, 6135, 6143, 6181, 6228, 6717, 6740, 6759, 6773,
6786, 6797, 6798, 6810, 6826, 6836, 6843, 6857, 6858, 6859, 6864, 6866, 6873,
6883, 6884, 6885, 6888, 6889, 6893, 6903, 6904, 6920, 6925, 6932, 6936, 6954,
6958, 6959, 6964, 6973, 6974, 6982, 6988, 6989, 6992, 10029, 10033, 10066,
10145, 10417, 10419, 10429, 10434, 10461, 10477, 10481, 10498, 10499, 13012,
13028, 13032, 13034, 13122, 13125, 13131, 13146, 13159, 13175, 13198, 13216,
13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252,
13254, 13256, 13278, 13279, 13295, 13611, 13613, 13632, 13636, 13648, 13649,
13650, 13654, 13655, 13667, 13698, 13706, 13712, 13726, 13728, 13741, 13744,
13869, 13870, 13871, 13872, 13887, 13892, 13893, 13896, 13909, 13912, 13920,
13957, 13973, 13974, 13975, 14076, 14078, 14081, 14176, 16027, 16278, 16294,
16399, 16473, 16552, 16572, 16609, 17166, 17248, 17298, 17494, 17516, 17540,
17567, 17568, 17569, 17570, 17571, 17582, 17588, 17589, 17591, 17634, 17658,
17659, 17660, 17661, 17662, 17671, 17672, 17673, 19050, 19124, 19176, 19304,
19329, 19336, 25007, 25448, 25627, 25628, 25898, 26015, 26023, 26024, 26026,
26028, 26029, 26044, 26045, 26130, 26141, 26153, 26155, 26156, 26205, 26206,
26208, 26209, 26210, 26273, 26274, 26283, 28043, 28077, 28079, 28081, 28105,
28148, 28179, 28243, 31113, 34031, 34348, 34734, 35156, 35482, 35483, 35584,
35585, 35596, 37387, 37582, 37583, 37906, 37949, 37951, 37952, 37955, 37967,
37968, 37978, 37980, 37989, 37999, 38005, 38011, 38012, 38013, 38068, 38082,
38085, 38090, 38092, 38093, 38099, 38100, 38103, 38128, 38129, 38130, 38131,
38132, 38135, 38140, 38148, 38157, 38176, 38193, 38194, 38197, 38251, 38253,
38258, 38259, 38281, 38299, 38300, 38319, 38323, 38350, 38354, 38367, 38368,
38421, 38446, 38606, 38609, 38621, 38622, 38633, 38667, 38684, 38694, 38726,
38741, 38742, 38746, 38747, 38866, 38867, 38875, 38876, 38877, 38878, 38887,
38900, 38927, 38950, 38951, 38952, 38953, 38979, 38980, 38999, 40092, 40189,
40203, 40263, 40476, 40511, 40623, 40686, 40899, 40920, 40933, 40934, 40939,
40972, 41009, 41036, 41037, 41041, 41042, 41061, 41074, 41081, 41088, 41089,
41090, 41091, 41093, 41097, 41100, 41101, 41106, 41110, 41119, 41126, 41144,
41158, 41168, 41244, 41259, 41260, 41261, 41270, 41283, 41285, 41334, 41353,
41384, 41401, 41408, 41419, 41421, 41434, 41438, 41464, 41469, 41471, 41472,
41473, 43259, 43269, 43342, 43450, 43451, 43522, 43685, 43912, 44006, 44769,
44795, 44796, 44797, 44798, 44799, 44800, 44801, 44831, 44851, 44889, 44949,
44963, 45015, 45027, 45028, 45030, 45031, 45034, 45035, 45040, 45043, 45064,
45093, 46114, 46326, 46413, 46656, 46668, 46845, 46870, 46873, 46876, 46969,
46985, 47061, 47068, 47092, 47099, 47116, 47148, 47150, 47173, 47175, 47176,
47182, 47186, 47267, 49052, 49053, 49087, 49167, 49308, 50232, 50233, 50234,
50237, 50341, 50342, 50343, 50386, 52452, 52453, 52454, 52457, 52458, 52474,
52475, 52490, 58153, 58204, 58227, 58238, 58241, 58257, 58392, 58624, 58733,
58753, 58754, 58767, 58861, 58862, 58867, 58965, 58969, 58970, 58971, 59017,
59033, 59226, 59227, 59244, 59284, 59362, 59402, 59403, 59404, 59405, 59406,
59407, 59449, 59450, 59509, 59517, 59519, 59543, 59550, 59561, 59563, 59570,
59609, 59649, 59664, 59665, 59668, 59669, 61072, 61387, 61423, 61458, 61576,
61968, 62002, 62282, 62296, 62342, 62431, 62468, 62469, 62477, 62499, 62500,
62501, 62553, 62602, 62603, 62604, 62609, 62616, 62617, 62665, 62766, 62769,
62771, 62783, 62883, 62884, 62886, 62890, 62928, 62929, 62935, 62939, 62995,
64085, 64162, 64163, 64208, 64283, 64322, 64360, 64369, 64374, 64411, 64504,
64657, 65170, 67189, 67290, 67447, 67535, 73296, 73340, 73351, 74062, 74063,
74083, 76034, 76077, 76159, 76193, 76194, 76215, 76222, 76336, 76369, 76370,
76392, 76393, 76440, 76457, 76458, 76496, 76524, 76579, 76586, 76803, 76819,
76835, 76836, 76846, 76888, 76889, 76891, 76894, 76905, 76906, 76908, 76920,
76921, 76922, 76926, 76943, 76949, 76969, 76970, 76971, 76981, 76991, 76998,
80316, 80333, 82557, 82558, 82559, 82560, 82568, 82569, 82614, 82629, 82631,
82632, 82647, 82648, 82654, 82658, 82659, 82686, 82705, 82718, 82723, 82732,
82808, 82826, 82828, 82832, 82833, 82835, 82919, 82938, 83008, 83009, 83010,
83011, 83012, 83029, 83037, 83043, 83305, 83331, 83332, 83338, 83341, 83371,
83372, 83390, 83391, 83565, 83566, 83603, 83614, 83619, 83652, 83653, 83699,
83800, 83801, 83866, 83900, 83901, 83908, 83942, 83948, 83960, 83998, 84419,
84439, 84440, 84453, 84454, 84455, 84456, 84457, 84458, 84488, 84497, 84701,
84705, 84723, 84731, 84817, 84818, 84837, 84846, 84847, 84848, 84849, 84891,
84894, 84929, 84932, 84937, 84943, 84965, 84972, 85009, 85036, 85053, 85063,
85066, 85069, 85103, 85115, 85118, 85151, 85152, 85162, 85164, 85181, 85193,
85194, 85199, 85439, 85461, 85462, 85463, 85466, 85468, 85627, 85628, 85699,
85860, 86014, 86016, 86073, 86075, 86117, 86119, 86120, 86123, 86141, 86210,
86211, 86212, 86219, 86220, 86225, 86227, 86230, 86231, 86266, 86267, 86268,
86269, 86270, 86279, 86300, 86301, 86302, 86304, 86306, 86307, 86308, 86311,
86312, 86336, 86337, 86338, 86357, 86361, 86369, 86385, 86388, 86392, 86402,
86455, 86472, 86493, 86507, 86544, 86546, 86550, 86602, 86605, 86614, 86615,
86621, 86902, 86904, 86919, 86920, 86921, 86943, 86951, 86963, 86973, 86974,
87003, 87014, 87015, 87025, 87026, 87027, 87028, 87032, 87039, 87049, 87057,
87071, 87073, 87074, 87082, 87141, 87144, 87301, 87303, 87321, 87338, 87602,
87606, 87608, 100039, 100094, 100203, 100244, 100245, 100433, 100437, 100439,
100455, 100490, 100544, 100547, 100569, 100571, 100572, 100573, 100584, 100591,
100602, 100616, 100617, 100634, 100642, 100659, 100678, 100699, 100705, 100772,
100782, 100806, 100814, 100824, 100827, 100830, 100831, 100836, 100853, 100868,
100871, 100872, 100885, 100891, 100995, 100998, 101029, 101068, 101081, 101082,
101189, 101209, 101218, 101315, 101379, 101380, 101405, 101410, 101436, 101437,
101553, 101559, 101592, 101638, 101702, 101703, 101704, 101705, 101882, 101883,
101885, 101933, 101944, 101947, 101980, 101984, 101985, 101986, 101989, 101997,
102010, 102016, 102017, 102020, 102022, 102023, 102026, 102027, 102040, 102080,
102108, 102113, 102122, 102124, 102128, 102129, 102134, 102291, 102355, 102358,
102360, 102421, 102443, 102456, 102470, 102494, 102495, 102496, 102509, 102528,
102529, 102530, 102605, 102618, 102619, 102620, 102621, 102626, 102646, 102648,
102649, 102706, 102712, 102721, 102725, 102726, 102727, 102775, 102779, 102784,
102792, 102891, 102898, 102901, 102902, 102904, 102909, 102910, 102920, 102927,
102981, 102997, 102998, 103001, 103010, 103024, 103025, 103031, 103044, 103048,
103049, 103054, 103067, 103073, 103074, 103102, 103104, 103105, 103114, 103127,
103138, 103155, 103156, 103162, 103194, 103195, 103203, 103206, 103208, 103251,
103259, 103269, 103277, 103288, 103311, 103314, 103332, 103334, 103352, 103358,
103360, 103365, 103369, 103386, 103412, 103413, 103425, 103428, 103429, 103430,
103431, 103432, 103433, 103440, 103441, 103443, 103444, 103500, 103501, 103503,
103521, 103524, 103531, 103532, 103543, 103549, 103560, 103586, 103598, 103626,
103654, 103700, 103708, 103720, 103728, 103736, 103749, 103755, 103775, 103790,
103792, 103794, 103854, 103857, 103858, 103859, 103871, 103872, 103874, 103887,
103888, 103913, 103945, 103954, 103960, 103961, 103971, 103984, 104014, 104035,
104081, 104151, 104161, 104168, 104180, 104185, 104191, 104228, 104272, 104338,
104342, 104370, 104371, 104372, 104387, 104389, 104453, 104460, 104461, 104481,
104609, 104615, 104616, 104617, 104634, 104659, 104665, 104896, 104907, 105072,
105104, 105110, 105150, 105151, 105185, 105219, 105220, 105226, 105233, 105241,
105349, 105508, 105510, 105633, 105638, 105644, 105646, 105662, 105721, 105743,
105899, 105901, 105949, 105957, 250002, 250057, 250090, 250100, 250126, 250137,
250166, 250196, 250221, 250413, 250439, 250480, 250677, 250678, 250693, 250754,
250779, 250780, 250827, 250846, 251096, 395962, 500001, 500037, 500039, 500040,
504115, 504117, 504122, 504355, 504524, 504607, 504610, 504668, 504673, 504731,
504761, 504811, 504844, 504910, 504938, 505011, 505053, 505055, 505137, 505138,
505452, 505512, 505661, 505733, 505757, 505775, 505810, 505814, 505904, 505963,
505967, 505988, 506022, 506066, 506074, 506156, 506157, 506187, 506193, 506214,
506320, 506323, 506332, 506333, 506525, 506526, 506799, 506800, 506831, 506833,
506834, 506838, 506840, 519113, 519119, 519140, 519144, 519146, 519529, 519551,
519565, 519731, 519732, 519734, 519736, 519775, 519803, 519816, 519871, 520048,
520063, 520184, 520242, 520282, 520410, 520531, 520576, 520581, 520669, 520764,
520770, 520772, 520775, 520846, 521104, 521107, 521127, 521327, 521371, 521377,
521378, 521382, 521383, 521384, 521385, 521395, 521449, 521450, 521455, 521522,
521583, 521604, 521649, 521671, 521681, 521688, 521709, 521870, 521871, 521898,
521936, 521964, 521979, 521994, 521996, 522132, 522179, 522206, 522242, 522251,
522356, 522357, 522436, 522442, 522476, 530406, 530429, 530515, 530574, 530576,
530610, 530620, 531650, 531711, 531746, 531751, 531775, 531778, 531854, 531855,
531859, 531933, 532067, 532072, 532082, 532110, 532146, 532147, 532289, 532291,
532423, 532474, 532480, 532775, 532776, 532778, 532781, 532802, 532829, 532841,
532982, 533115, 533178, 533237, 533239, 533245, 533248, 533249, 533300, 533310,
533311, 533330, 533331, 533352, 533472, 533474, 533475, 533524, 533544, 533555,
533557, 533564, 533692, 533715, 533765, 533777, 533789, 533901, 533902, 533919,
534187, 534201, 534209, 534240, 534243, 534244, 534245, 534261, 534272, 534304,
534408, 534417, 534421, 534422, 534425, 534426, 534429, 534487, 534586, 534602,
534605, 534606, 534607, 534608, 534641, 534642, 534670, 534780, 534804, 534823,
534831, 534846, 534849, 534997, 535214, 535219, 535234, 535249, 535270, 535369,
535377, 535417, 535423, 535430, 535431, 535432, 535433, 535434, 535435, 535438,
535452, 535453, 535454, 535455, 535456, 535457, 535458, 535499, 535666, 535721,
535747, 535758, 535760, 535784, 535910, 535922, 535960, 536012, 536013, 536050,
536402, 536429, 536432, 536474, 536613, 536619, 536630, 536644, 536663, 536707,
536766, 536797, 536800, 536822, 536825, 536837, 536838, 536904, 536934, 536967,
536968, 536980, 537047, 537051, 537054, 537131, 537330, 537447, 537465, 537556,
537587, 537632, 537645, 537696, 537893, 537894, 537923, 537942, 537969, 538006,
538064, 538066, 538100, 538137, 538140, 538155, 538268, 538317, 538352, 538363,
538450, 538513, 538515, 538518, 538527, 538581, 538855, 538856, 538864, 538900,
538978, 539023, 539024, 539025, 539026, 539027, 539028, 539029, 539039, 539091,
539092, 539093, 539163, 539164, 539173, 539182, 539620, 539631, 539724, 539725,
539863, 539881, 540011, 540028, 540055, 540081, 540087, 540096, 540097, 540098,
540135, 540157, 540158, 540164, 540175, 540178, 540200, 540216, 540260, 540262,
540268, 540366, 540431, 540446, 540467, 540473, 540501, 540502, 540503, 540506,
540762, 540858, 540970, 541064, 541068, 541089, 541175, 541179, 541242, 541243,
541244, 541264, 541270, 541323, 541327, 541351, 541497, 541514, 541536, 541586,
541644, 541692, 541733, 541744, 541764, 541837, 541914, X0101, X0389, X0568,
X0715, X0971, X0976, X1040, X1070, X1143, X1156, X1157, X1182, X1183, X1195,
X1196, X1200, X1208, X1209, X1211, X1212, X1217, X1220, X1225, X1226, X1265,
X1276, X1285, X1291, X1292, X1303, X1311, X1331, X1332, X1334, X1336, X1337,
X1359, X1360, X1361, X1400, X1406, X1415, X1416, X1421, X1422, X1423, X1427,
X1470, X1560, X1597, X1610, X1651, X1652, X1658, X1660, X1667, X1682, X1701,
X1702, X1727, X1728, X1748, X1754, X1773;
b) Site numbers 103982, 104073, 105158, 105629, 504343, 505773;
c) Site numbers: 6901, 6961, 6983, 6987, 10000, 10002, 10006, 10178, 10392, 10393, 10406, 10410, 10418, 10435, 10493, 13173, 13178, 13195, 13215, 13245, 13257, 13283, 13284, 13293, 13877, 13880, 13895, 13908, 13956, 13968, 13969, 13970, 13972, 13984, 13999, 14070, 14169, 14177, 26140, 26154, 26157, 26211, 26212, 26213, 26275, 38086, 38091, 38106, 38120, 38141, 38142, 38149, 38195, 38196, 38207, 38268, 38279, 38314, 38318, 38361, 38417, 38423, 38424, 38434, 38505, 38528, 38529, 38539, 38541, 38555, 38559, 38584, 38591, 38607, 38608, 38625, 38626, 38634, 38656, 38679, 38689, 38692, 38693, 38695, 38712, 38743, 38745, 38914, 38940, 38958, 38972, 38977, 38978, 38988, 40930, 40936, 40937, 40973, 41035, 41040, 41063, 41096, 41098, 41099, 41105, 41107, 41120, 41121, 41131, 41135, 41235, 41236, 41237, 41238, 41284, 41286, 41352, 41420, 41435, 41463, 41465, 41466, 41468, 44804, 44805, 44806, 44983, 45029, 45070, 45091, 45092, 50220, 50221, 50230, 50322, 50323, 50427, 50446, 50447, 52450, 52456, 52491, 59569, 59634, 59652, 59661, 59666, 62663, 62664, 62797, 62802, 62838, 62868, 62888, 62889, 62934, 62973, 62987, 62994, 62996, 62997, 73858, 76192, 76216, 76355, 76356, 76357, 76371, 76372, 76379, 76381, 76382, 76391, 76403, 76439, 76456, 76495, 76578, 76763, 76805, 76827, 76829, 76837, 76838, 76843, 76844, 76874, 76925, 76940, 76957, 76958, 76959, 76960, 76965, 76967, 76973, 76982, 80318, 80319, 80339, 82503, 82515, 82516, 82561, 82570, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82918, 82920, 82942, 82943, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83646, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84459, 84460, 84461, 84703, 84704, 84851, 84857, 84858, 84889, 84893, 84895, 84928, 84931, 84936, 84938, 84939, 84949, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85161, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85464, 85465, 85467, 85484, 85486, 85487, 85492, 85493, 85494, 85683, 86015, 86059, 86060, 86070, 86071, 86078, 86140, 86213, 86215, 86216, 86221, 86226, 86228, 86229, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86389, 86391, 86394, 86395, 86397, 86400, 86403, 86543, 86547, 86579, 86600, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86624, 86901, 86903, 86938, 86939, 86942, 86964, 86966, 86970, 86976, 86979, 86980, 87005, 87016, 87017, 87031, 87045, 87046, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87177, 87178, 87196, 87313, 87320, 87333, 87363, 87510, 87520, 87601, 87609, 87610, 100428, 100438, 100443, 100457, 100481, 100489, 100495, 100518, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100676, 100677, 100698, 100727, 100770, 100818, 100834, 100835, 100838, 100848, 100855, 100867, 100876, 100882, 100883, 100947, 100957, 101039, 101041, 101054, 101076, 101079, 101080, 101132, 101133, 101134, 101141, 101142, 101143, 101144, 101145, 101147, 101148, 101149, 101161, 101191, 101204, 101212, 101240, 101555, 101558, 101563, 101569, 101586, 101643, 101837, 101871, 101872, 101935, 101936, 101937, 101955, 101958, 101959, 101960, 102099, 102107, 102132, 102163, 102168, 102169, 102170, 102174, 102245, 102337, 102338, 102339, 102341, 102342, 102372, 102376, 102384, 102385, 102387, 102388, 102445, 102462, 102466, 102491, 102541, 102552, 102559, 102567, 102585, 102586, 102587, 102590, 102591, 102606, 102608, 102609, 102622, 102630, 102634, 102647, 102700, 102701, 102794, 102839, 102876, 102893, 102903, 102917, 102918, 102921, 102922, 102925, 103007, 103008, 103037, 103057, 103115, 103120, 103121, 103146, 103163, 103180, 103184, 103185, 103200, 103204, 103252, 103260, 103276, 103279, 103284, 103310, 103337, 103387, 103421, 103422, 103424, 103427, 103496, 103497, 103504, 103517, 103595, 103597, 103606, 103653, 103724, 103730, 103785, 103786, 103876, 103883, 103895, 103917, 103943, 103948, 103963, 103977, 104010, 104013, 104051, 104059, 104071, 104113, 104135, 104153, 104162, 104164, 104165, 104181, 104182, 104204, 104205, 104268, 104283, 104339, 104404, 104471, 104508, 104629, 104794, 104801, 104842, 104854, 104855, 104881, 104893, 104931, 105109, 105155, 105202, 105238, 105242, 105295, 105337, 105414, 105649, 105696, 105769, 250043, 250069, 250092, 250139, 250313, 250679, 500012, 504137, 504329, 504882, 505056, 505640, 506168, 506171, 519562, 519766, 519776, 519826, 520262, 520279, 520280, 521003, 530692, 532044, 534057, 534433, 534873, 535262, X1027, X1041, X1055, X1056, X1089, X1136, X1140, X1141, X1142, X1153, X1165, X1166, X1180, X1181, X1194, X1201, X1229, X1230, X1234, X1264, X1266, X1290, X1295, X1299, X1304, X1320, X1338, X1362, X1363, X1399, X1405, X1417, X1446, X1449, X1467, X1469, X1501, X1502, X1504, X1507, X1510, X1515, X1521, X1543, X1561, X1565, X1568, X1569, X1572, X1573, X1632, X1640, X1644, X1653, X1671, X1681, X1705, X1706, X1713, X1749, X1752, X1764, X1769;
d) Site numbers 102549, 102551, 103130, 103515, 103522, 103523, 103666, 104078, 104614, 104812, 105482, 105589, 105678, 105775, 105777, 500003, 500032, 504642, 504643, 504803, 504804, 504879, 504941, 504962, 504966, 505062, 505063, 505104, 505255, 505349, 505539, 505540, 505606, 505806, 505871, 505926, 506117, 506199, 506205, 506208, 506210, 506231, 506233, 506248, 506249, 506250, 506251, 506275, 506276, 506277, 506278, 506281, 506305, 506554, 506828, 506844, 506845, 519117, 519121, 519122, 519128, 519152, 519773, 519879, 519900, 520182, 520183, 520209, 520300, 520301, 520516, 520707, 520798, 520806, 521135, 521153, 521606, 521654, 521658, 521869, 521942, 522015, 522193, 522271, 522399, 522401, 522443, 522470, 522480, 530573, 530607, 530795, 530797, 530798, 531769, 531832, 531857, 531860, 532069, 532107, 532137, 532139, 532157, 532170, 532174, 532177, 532360, 532397, 532398, 532426, 532471, 532477, 532479, 532766, 532779, 532842, 532971, 532978, 533234, 533240, 533243, 533313, 533389, 533396, 533451, 533470, 533490, 533491, 533528, 533558, 533562, 533565, 533566, 533574, 533766, 533770, 533771, 533867, 533898, 533914, 533918, 533968, 534207, 534419, 534434, 534596, 534599, 534600, 534615, 534644, 534647, 534675, 534677, 534694, 534782, 534803, 534805, 534815, 534822, 534824, 534850, 534867, 534945, 535021, 535233, 535255, 535365, 535378, 535382, 535436, 535437, 535500, 535613, 535757, 535765, 535771, 535785, 535908, 535995, 536011, 536051, 536081, 536082, 536179, 536200, 536394, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536914, 536933, 536938, 536941, 536973, 536984, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537654, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537967, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539411, 539419, 539488, 539501, 539519, 539527, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541075, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884;
e) Site numbers 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490;
f) Site numbers 102666, 104083, 104530, 105193, 105194, 105394, 504340, 504341,
505039, 505345, 505346, 506155, 506236, 506247, 519574, 532087, 532140, 532151,
532213, 532703, 533312, 533473, 533559, 534247, 535714, 535767, 536019, 536091,
536146, 536720, 536935, 537083, 537669, 537787, 538440, 539457, 539598, 539990,
540252, 541263, 541474
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell,
WA, by letter dated July 9, 2007 and August 20, 2007. Firm initiated
recall is ongoing.
REASON
Units do not comply with the requirement to provide automatic beam limitation
within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane
of the image receptor during radiographic procedures.
VOLUME OF PRODUCT IN COMMERCE
2,583 units
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4
and 2380179 containing Proteus Operator Console model# 2259976, Recall # Z-1087-2007
CODE
Lot #’s: 30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8,
35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3,
36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems, LLC, Waukesha, WI, by visit beginning on
May 31, 2006. Firm initiated recall is complete.
REASON
Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator
Console of the Proteus XR/a General Purpose Radiographic Systems were not properly
labeled.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
WA, KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, GA
___________________________________
PRODUCT
GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and
vascular imaging system. Recall # Z-1088-2007
CODE
Serial numbers: 00000459256BU4, 00000459553BU4, 00000459554BU2, 00000459555BU9,
00000459556BU7, 00000459557BU5, 00000460056BU5, 00000460057BU3, 00000460058BU1,
00000460059BU9, 00000460060BU7, 00000460063BU1, 00000460065BU6, 00000460066BU4,
00000460067BU2, 00000461642BU1, 00000461643BU9, 00000461644BU7, 00000461645BU4,
00000462898BU8, 00000462899BU6, 00000462900BU2, 00000462901BU0, 00000462902BU8,
00000462903BU6, 00000462904BU4, 00000462905BU1, 00000462906BU9, 00000462907BU7,
00000463613BU2, 00000463630BU4, 00000463631BU2, 00000463632BU0, 00000463633BU8,
00000463634BU6, 00000463636BU1, 00000463637BU9, 00000463638BU7, 00000463639BU5,
00000463841BU7, 00000467440BU4, 00000467441BU2, 00000467442BU0, 00000467443BU8,
00000467444BU6, 00000467445BU3, 00000467446BU1, 00000467447BU9, 00000467448BU7,
00000467449BU5, 00000467451BU1, 00000469541BU7, 00000469542BU5, 00000469543BU3,
00000469544BU1, 00000469545BU6, 00000469546BU6, 00000469547BU4, 00000469548BU2,
00000469549BU0, 00000469550BU8, 00000470643BU8, 00000470644BU6, 00000470645BU3,
00000470646BU1, 00000470647BU9, 00000470648BU7, 00000470649BU5, 00000470650BU3,
00000470651BU1, 00000470652BU9, 00000471493BU7, 00000471494BU5, 00000471495BU2,
00000471496BU0, 00000471497BU8, 00000471498BU6, 00000471499BU4, 00000471500BU9,
00000471501BU7, 00000471502BU5, 00000472676BU6, 00000477489BU9, 00000477490BU7,
00000477491BU5, 00000477492BU3, 00000477493BU1, 00000477494BU9, 00000477495BU6,
00000477496BU4, 00000477497BU2, 00000477498BU0, 00000477893BU2, 00000479230BU5,
00000479231BU3, 00000479232BU1, 00000479233BU9, 00000479234BU7, 00000479235BU4,
00000479236BU2, 00000479237BU0, 00000479238BU8, 00000479239BU6, 00000479937BU5,
00000479945BU8, 00000479946BU6, 00000479947BU4, 00000479948BU2, 00000479949BU0,
00000479950BU8, 00000479951BU6, 00000479952BU4, 00000479953BU2, 00000479954BU0,
00000482511BU3, 00000482512BU1, 00000482513BU9, 00000482514BU7, 00000482515BU4,
00000482516BU2, 00000482517BU0, 00000482518BU8, 00000482519BU6, 00000482520BU4,
00000484054BU2, 00000485072BU3, 00000485074BU9, 00000485075BU6, 00000485076BU4,
00000485077BU2, 00000485078BU0, 00000485079BU8, 00000485080BU6, 00000485081BU4,
00000487465BU7, 00000487466BU5, 00000487469BU9, 00000487470BU7, 00000487471BU5,
00000487472BU3, 00000487473BU1, 00000487474BU9, 00000491019BU6, 00000491020BU4,
00000491021BU2, 00000491022BU0, 00000491023BU8, 00000491025BU3, 00000491027BU9,
00000491028BU7, 00000491032BU9, 00000492823BU0, 00000492824BU8, 00000492825BU5,
00000492827BU1, 00000492828BU9, 00000492830BU5, 00000492831BU3, 00000494960BU8,
00000504480BU5, 00000508755BU6, 00004600057BU3
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems, LLC, Waukesha, WI, by visit
beginning on June 6, 2006.
Manufacturer: General Electric Medical Systems, SCS, Buc Cedex, France. Firm
initiated recall is complete.
REASON
The systems do not contain a certification label on the C2 Cabinet (Beam-limiting
control).
VOLUME OF PRODUCT IN COMMERCE
161 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Laser Distance and Level Transmitters, Model No. LT4C,
Recall # Z-1120-2007;
b) Laser Level Transmitters, Model No. LM4C, Recall # Z-1121-2007;
c) LaserTrak, Model No. LT80, Recall # Z-1122-2007;
d) Laser Meter, Model No. LTM80, Recall # Z-1123-2007;
e) Laser Distance and Level Transmitters, Model No. LT200, Recall # Z-1124-2007;
f) Laser Distance and Level Transmitters, Model No. LM200, Recall # Z-1125-2007;
g) Laser Distance and Level Transmitters, Model No. LM02, Recall # Z-1126-2007
CODE
a) Model No. LT4C;
b) Model No. LM4C;
c) Model No. LT80;
d) Model No. LM80;
e) Model No. LT200;
f) Model No. LM200;
g) Model No. LM02
RECALLING FIRM/MANUFACTURER
K Tex, Galvez, LA, by letter dated November 3, 2006. Firm initiated recall is
ongoing.
REASON
Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10,
1040.11, 1002.10-improper classification, incomplete labeling, incomplete user
information and failure to submit required product reports)
VOLUME OF PRODUCT IN COMMERCE
1,008 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software;
composed of several modules including the core Pinnacle3 functionality, Syntegra
(TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of
a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating
system and software, and a UNIX terminal emulation package on a personal computer,
which allows the user to enter patient data into the system, use that data to
construct a plan for radiation therapy, and evaluate the plan- Philips Medical
Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG
(with software versions 7.6C, 8.0d and 8.0h), Recall # Z-1212-2007
CODE
Pinnacle3 Version 7.6c Software Kit Model #9200-0652A-ENG Pinnacle3 Version 8.0d
Software Kit Model #9200-0700A-ENG Pinnacle3 Version 8.0d p 1 Software Kit Model
#9200-0700B-ENG Pinnacle3 Version 8.0h Software Kit Model #9200-0700C-ENG
RECALLING FIRM/MANUFACTURER
Philips Nuclear Medicine, Inc., Fitchburg, WI, by letter on August 21, 2007. Firm
initiated recall is ongoing.
REASON
Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due
to a software malfunction.
VOLUME OF PRODUCT IN COMMERCE
1,407 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal
Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics. Product numbers: 5537-G-109,
5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128,
5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222,
5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316,
5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411,
5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431,
5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525,
5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619,
5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713,
5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809,
5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828,
5537-G-831, Recall # Z-1231-2007
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 2, 2007.
Firm initiated recall is ongoing.
REASON
Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification
anomaly related to length, resulting in a potential for the post to slightly
protrude above the top surface of the plastic post.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
GA, OH, MN and TX
___________________________________
PRODUCT
a) Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton,
Recall # Z-1235-2007;
b) Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per
carton,
Recall # Z-1236-2007
CODE
a) Item number 531584. Lot number 070606SFR exp 6/09;
b) Item number 531587. Lot numbers 070507SFR exp 5/09, 070523SFR exp 5/09
070529SFR exp 6/09, 070601SFR exp 6/09, 070605SFR exp 6/09,
070608SFR exp 6/09,
070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09,
and 070625SFR exp 6/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on July 31,
2007 and by press release on September 14, 2007.
Manufacturer: AM2PAT, Angier, NC. Firm initiated recall is ongoing.
REASON
Particulate matter in product.
VOLUME OF PRODUCT IN COMMERCE
1,325,760 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities
Recall # Z-1243-2007
CODE
Radiology 2007 Cumulative Production Package 25143.
RECALLING FIRM/MANUFACTURER
Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters
dated August 29, 2007 and September 4, 2007. Firm initiated recall is complete.
REASON
Defects in the Auto Launch functionality make it possible for a mismatch of patient
data.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200,
A4.3 SW level, Recall # Z-1244-2007
CODE
Systems manufactured or upgraded to Model IS1200 hardware/software level in this
time frame: 2/17/2000 - 3/27/2007
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 7, 2007.
Firm initiated recall is ongoing.
REASON
Under certain circumstances, the product's software may crash and require a manual
override or restart before functioning again. In addition, there is an unrelated
addendum to the User Manual to clarify an icon not described in the previous
User Manual.
VOLUME OF PRODUCT IN COMMERCE
405 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed
circuit board assembly), endoscopic instrument control system. Model number IS2000,
part number 351040-04, Recall # Z-1245-2007
CODE
System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066,
SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077,
SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117,
SG118, SG120, SG121, SG126, SG174, SG175, SG184
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 12,
2007. Firm initiated recall is ongoing.
REASON
Product may malfunction and fail to start up on AC power.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Trident PSL Acetabular Shell; Arc Deposited; Hydroxylapatite Coated; Cluster
Screw Holes; Hip prosthesis component. Recall # Z-1261-2007
CODE
Catalog number/ lot code: 540-11-56F 36906101 540-11-58G 37048901 540-11-58G
37122001 542-11-46D 34977701 542-11-46D 35105901 542-11-46D 35382701 542-11-46D
35483101 542-11-46D 35525001 542-11-46D 35584201 542-11-46D 37497001 542-11-46D
37830601 542-11-46D 37884701 542-11-46D 38034101 542-11-46D 38124501 542-11-48D
35028401 542-11-48D 35332701 542-11-48D 35406002 542-11-48D 35406003 542-11-48D
35687701 542-11-48D 35726401 542-11-48D 35834801 542-11-48D 37790101 542-11-48D
37891501 542-11-48D 38025001 542-11-48D 38025002 542-11-48D 38160501 542-11-50E
35032701 542-11-50E 35207301 542-11-50E 35385903 542-11-50E 35428901 542-11-50E
35428903 542-11-50E 35481501 542-11-50E 35481502 542-11-50E 35481502 542-11-50E
35515802 542-11-50E 35827902 542-11-50E 36966303 542-11-50E 37344301 542-11-50E
37515302 542-11-50E 37695201 542-11-50E 37888201 542-11-50E 37920201 542-11-50E
38245801 542-11-50E 38274303 542-11-52E 32886803 542-11-52E 35018402 542-11-52E
35018403 542-11-52E 35018404 542-11-52E 35085001 542-11-52E 35199201 542-11-52E
35199202 542-11-52E 35199204 542-11-52E 35325401 542-11-52E 35325403 542-11-52E
35373402 542-11-52E 35373403 542-11-52E 35419904 542-11-52E 35726002 542-11-52E
35866302 542-11-52E 35866304 542-11-52E 37057001 542-11-52E 37096702 542-11-52E
37368002 542-11-52E 37886202 542-11-52E 37886204 542-11-52E 37886206 542-11-52E
37925602 542-11-52E 37995901 542-11-52E 37995902 542-11-54F 35091602 542-11-54F
35186502 542-11-54F 35732703 542-11-54F 35868801 542-11-54F 35965101 542-11-54F
37443401 542-11-54F 37443403 542-11-54F 37789201 542-11-54F 37916502 542-11-54F
38095601 542-11-54F 38223203 542-11-56F 35081001 542-11-56F 35225301 542-11-56F
35225302 542-11-56F 35225303 542-11-56F 35290801 542-11-56F 35335101 542-11-56F
35524501 542-11-56F 35535102 542-11-56F 35831001 542-11-56F 36330001 542-11-56F
36542101 542-11-56F 36542102 542-11-56F 36768001 542-11-56F 36907201 542-11-56F
37050902 542-11-56F 37461501 542-11-56F 37743301 542-11-56F 38099001 542-11-58G
35638002 542-11-58G 35959701 542-11-58G 35959702 542-11-58G 36052801 542-11-58G
36137301 542-11-58G 36195501 542-11-58G 36195502 542-11-58G 36332802 542-11-58G
36372301 542-11-58G 36412601 542-11-58G 36430601 542-11-58G 36489601 542-11-58G
36489602 542-11-58G 36553001 542-11-58G 36583801 542-11-58G 36633201 542-11-58G
36758901 542-11-58G 36758902 542-11-58G 36898201 542-11-58G 37049101 542-11-58G
37049102 542-11-58G 37049103 542-11-58G 37122401 542-11-58G 37122402 542-11-58G
37122403 542-11-58G 37173201 542-11-58G 37242901 542-11-58G 37242902 542-11-58G
37279901 542-11-58G 37332301 542-11-58G 37500801 542-11-58G 37500801 542-11-58G
37500803 542-11-58G 37826804 542-11-60G 34806101 542-11-60G 34907101 542-11-60G
35666901 542-11-60G 35946101 542-11-60G 36002201 542-11-60G 36406701 542-11-60G
36435401 542-11-60G 36765101 542-11-60G 37119701 542-11-60G 37119702 542-11-60G
37273901 542-11-60G 37402101 542-11-62G 37358901 542-11-62H 34930801 542-11-62H
35272101 542-11-62H 35508901 542-11-62H 36270401 542-11-62H 36842101 542-11-64H
36406301 542-11-64H 37082601 542-11-64H 37358801 542-11-64H 37859901
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on March 13, 2006.
Firm initiated recall is complete.
REASON
Dimensional anomaly.
VOLUME OF PRODUCT IN COMMERCE
1,220 units
DISTRIBUTION
Nationwide, Romania, Chile and Brazil
___________________________________
PRODUCT
Merit Medical Surgical Convenience Kits, Custom and SPPT,. Part numbers: K05-01767A,
K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q,
K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B,
K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F,
K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A,
K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A,
K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C,
SPPT-5F-7L/A, Recall # Z-1262-2007
CODE
Merit Lot Numbers: A339685, A342805, A343855, A344934, A348869, A350784, A350904,
A353811, A355556, A357384, A357617, A358608, A360773, A361301, A364800,A365752,
A366125, A366523, A367651, A371190, A372815, A374857, A375138, A375848, A376973,
A377976, A381997, A384786, A387975, F390117, F399800, F406192, F434870, F440785,
F440789, F440801, F440803, F442051, F449479, F449481, F449482, F449483, F453020,
F453170, F455150, F456553, F465539, F465540, F470421, F471056, F471659, F473566,
F474320, F476314, F476367, F476543, F476597, F477729, F480127, F480129, F480131,
F480140, F482129, F482853, F488460, F488709, F488858, F489432, F491275, F491462,
F491656, F491659, F492220, F492223, F494547, F495828, F496118, F496939, F502345,
F504184, F505776, F505782, F505785, F505786, F505790, F505794, F505799, F508595,
F509197, F511015, F513651, F514433, F514954, F514957, F515853, F517537, F517708,
F518306, F520504, F523595, F526626, F528413, F534059, F536871, F537731, F538716,
F548977, F548978
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc, South Jordan, UT, by letter on August 22, 2007.
Firm initiated recall is ongoing.
REASON
Expiration Dating; Some Convenience Kits contain medications and/or skin preparations
that may expire before the expiration date on the outer package label.
VOLUME OF PRODUCT IN COMMERCE
16,633 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil
is a two-channel, receive only coil that functions at 29.641 MHz band. It consists
of a cable and a coil (imaging) body. A portion of the cable is referred to as
the balun assembly or balun trap. The shoulder coil assembly is packaged in a
cardboard box with foam inserts. Recall # Recall Number : Z-1263-2007
CODE
Serial Numbers: 203, 303, 305, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316,
317, 318, 319, 320, 321, 323, 325, 326, 327, 328, 329, 330, 332, 333, 335, 336,
337, 338, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352,
353, 354, 355, 356, 357, 359, 360, 361, 362, 363, 364, 365, 366, 367, 368, 369,
370, 371, 372, 373, 374, 375, 377, 378, 379, 380, 381, 382, 383, 384, 385, 386,
387, 388, 389, 390,, 391, 392, 393, 394, 395, 396, 397, 398, 399, 400, 401, 402,,
403, 404, 405, 406, 407, 408, 410, 411, 412, 413, 414, 415 416, 417, 418, 419,
420, 421, 422, 424, 425, 426, 427, 429, 430, 431, 432, 434, 435, 436, 437, 438,
439, 440, 441, 442, 443, 445, 446, 447, 449, 450, 451, 452, 453, 454, 456, 457,
458, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 472, 473, 474, 475,
476, 477, 478, 479, 480, 481, 482, 483, 485, 486, 487, 488, 489, 491, 492, 493,
494, 495, 496, 497 499, 501, 502, 503, 504, 505, 509, 510, 512, 513, 514, 515
516, 517, 518, 519, 520, 521, 522, 523, 524, 527, 528, 529 530, 531, 532, 533,
534, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549,
550, 551, 552, 553, 554, 555, 556, 557, 559, 560, 561, 562, 563, 564, 565, 566,
567, 568, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579, 580, 581, 582, 583,
584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599,
600, 601, 602, 603
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter
on July 30, 2007.
Manufacturer: Hitachi Medical Corporation, Tokyo, Japan. Firm initiated recall
is ongoing.
REASON
Overheating; A portion (balun assembly) of the cable that connects the shoulder
coil to the actual MRI unit may malfunction and result in overheating of the
balun assembly. The overheating of the balun assembly could result in injury
to the patient or operator if either came into contact with the assembly.
VOLUME OF PRODUCT IN COMMERCE
273 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S,
Recall # Z-1264-2007;
b) Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S;
Recall # Z-1265-2007
CODE
a) Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655;
b) Lot # 31140; Serial Numbers BAHO45 through BAH144
RECALLING FIRM/MANUFACTURER
Spectrum Designs, Inc., Carpinteria, CA, by letters on July 24, 2007. Firm initiated
recall is ongoing.
REASON
Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin
implants instead of the nasal implant.
VOLUME OF PRODUCT IN COMMERCE
230 units
DISTRIBUTION
CA and China
___________________________________
PRODUCT
a) Davol Salute Fixation Reusable Handle Item Code: 0113024-Product
Code 9113024 (Refurbished), Recall # Z-1266-2007;
b) Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item
Numbers: 0113036-Product Code 9113036-(Refurbished),
Recall # Z-1267-2007;
c) Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-
Product Code: 9113037(Refurbished), Recall # Z- Z-1268-2007;
d) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;
5/Box, Item Number: 0113058, Recall Number : Z-1269-2007
e) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;
5/Box, Item Number: 0113035, Recall # Z-1270-2007;
f) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box,
Item Number: 0113059, Recall # Z-1271-2007;
g) Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box,
Item Number: 0113043m, Recall # Z-1272-2007;
h) Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box,
Item Number: 0113061, Recall # Z-1273-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letter
on July 16, 2007 and July 23,2007.
Manufacturer: BARD SHANNON LIMITED, Humacao, PR. Firm initiated recall is ongoing.
REASON
Malformed constructs (straight shots) may form causing injury to user/patient.
Abdominal mesh attachment system component, for use in hernia repair.
VOLUME OF PRODUCT IN COMMERCE
2,400 handles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Abbott Aeroset/Architect Clinical Chemistry, AST Activated (ASTA), List Number:
8D37-30, Recall # Z-1079-2007
CODE
Lot #46059HW00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Inc., South Pasadena, CA, by letter on April 04, 2007.
Firm initiated recall is ongoing.
REASON
Mislabeling: The empty cartridges supplied with Clinical Chemistry ASTA, lot
number 46059HW00, have an incorrect top label. The top label on the cartridge
incorrectly indicates ALTA instead of ASTA.
VOLUME OF PRODUCT IN COMMERCE
15 in the US and 680 units Internationally
DISTRIBUTION
IL, TX, Dominican Republic, El Salvador, Germany, Panama, and Jamaica
___________________________________
PRODUCT
Wheat Gluten, Batch No., Net Weight: 25 kg, Gross Weight 25.1 kg. Made in China,
Recall # V-301-2007
CODE
Lot: 788, 796, 798, 799, 806, 808, 809
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Scoular Company, Minneapolis, MN, by telephone on
March 30, 2007 and letter dated April 2, 2007.
Manufacturer: Xuzhou Anying Biologic Technology Development Co., LTD., Peixian,
China (Mainland). Firm initiated recall is ongoing.
REASON
The FDA detected melamine in certain lots of wheat gluten.
VOLUME OF PRODUCT IN COMMERCE
308,644 lbs
DISTRIBUTION
AL and NE
___________________________________
PRODUCT
a) SmartPak Live Smart Weight Management Chicken SPE custom packed in single
serving
container. Package insert identified as follows: LiveSmart
Weight Management Chicken
and Brown Rice Formula, Recall # V-1122-2007;
b) LiveSmart Adult Lamb and Brown Rice. Custom packed in single serving container,
Recall # V-1123-2007
CODE
All lots, all codes
RECALLING FIRM/MANUFACTURER
Smart Pak Equine Co., Plymouth, MA, by telephone, e-mail and letter dated April
20, 2007 and May 3, 2007. Firm initiated recall is ongoing.
REASON
Rice protein concentrate may have been tainted with melamine.
VOLUME OF PRODUCT IN COMMERCE
Approx 343 lbs.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Dick Van Patten's Natural Balance Venison & Brown Rice Formula Dog Treats,
14 oz. bags; UPC code: 7-23633-61400-9, Recall # V-1124-2007;
b) Dick Van Patten's Natural Balance Venison & Brown Rice Canned Dog Food,
13 oz can; UPC code: 7-23633-00155-3, Recall # V-1125-2007;
c) Dick Van Patten's Natural Balance Ultra Premium Dog Food Chicken Formula
Canned Dog Food, 13oz; UPC code: 7-23633-00153-3, Recall
# V-1126-2007;
d) Dick Van Patten's Natural Balance Ultra Premium Dog Food Beef Formula Canned
Dog Food, 13oz; UPC code: 7-23633-00152-6, Recall
# V-1127-2007;
e) Dick Van Patten's Natural Balance Ultra Premium Dog Food Lamb Formula Canned
Dog Food, 13oz; UPC code: 7-23633-00151-9, Recall # V-1128-2007;
f) Dick Van Patten's Natural Balance Ultra Premium Cat Food Ocean Fish Formula
Canned
Cat Food in 3oz and 6oz; UPC code: For the 3oz, 7-23633-00253-0;
for the 6 oz,
7-23633-00353-7, Recall # V-1129-2007
CODE
All date codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Balance Pet Food Inc., Pacoima, CA, by telephone
and e-mail and press release on April 13, 2007, and by press release and letters
on April 27, 2007.
Manufacturer: American Nutrition Incorporated, Ogden UT. Firm initiated
recall is ongoing.
REASON
Product has been manufactured with rice protein concentrate contaminated with
melamine.
VOLUME OF PRODUCT IN COMMERCE
Dog treats: 4744 cases/12 bags per case; Canned food: 283,530 cases/24 cans
per case
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
58% Protein Poultry Meal Blend. Product Code 1058, Recall # V-104-2007
CODE
Products sold between 12/1/06 through 3/16/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valley Proteins, Inc., Winchester, VA, by fax dated May
4, 2007.
Manufacturer: Valley Protein Inc., East Earl, PA. Firm initiated recall
is ongoing.
REASON
Product positive for melamine.
VOLUME OF PRODUCT IN COMMERCE
13,232,680 lbs
DISTRIBUTION
PA and DE
___________________________________
PRODUCT
1) AMERICA'S CHOICE, PREFERRED PET: Sliced Chicken, Hearts & Liver Dinner
Cat
Food packed in 3 oz cans, UPC 5480759117, Recall # V-107-2007;
2) BEST CHOICE: Sliced Beef Dinner in Gravy Cat Food packed in 5.5 oz cans,
UPC 7003836329, Recall # V-108-2007;
3) BEST CHOICE: Sliced Chicken Dinner Cat Food packed in 3 oz cans,
UPC 7003859960, Recall # V-109-2007;
4) CAT'S CHOICE: Sliced Chicken in Gravy packed in 5.5 oz cans,
UPC 8113169858, Recall # V-110-2007;
5) CAT'S CHOICE: Variety Pack packed in 5.5 oz cans, UPC 8113169861,
Recall # V-111-2007;
6) COMPANION: Sliced Chicken, Hearts & Liver Dinner Cat Food packed in
3 oz cans, UPC 8826700288, Recall # V-112-2007;
7) COMPANION: Sliced Beef Dinner Cat Food packed in 3 oz cans,
UPC 8826700283, Recall # V-113-2007;
8) COMPANION: Sliced Turkey Dinner Cat Food packed in 3 oz cans,
UPC 8826700287, Recall # V-114-2007;
9) COMPANION: Sliced Variety Pack Cat Food packed in 3 oz cans,
UPC 8826703352, Recall # V-115-2007;
10) COMPLIMENTS: Flaked Tuna Platter Cat Food packed in 85 gm cans,
UPC 5574235283, Recall # V-116-2007;
11) COMPLIMENTS: Flaked Trout Platter Cat Food packed in 85 gm cans,
UPC 5574235285, Recall # V-117-2007;
12) COMPLIMENTS: Flaked Beef Platter Cat Food packed in 85 gm cans,
UPC 5574235279, Recall # V-118-2007;
13) COMPLIMENTS: Chicken Cuts in Gravy Cat Food packed in 374 gm cans,
UPC 5574235303, Recall # V-119-2007;
14) COMPLIMENTS: Beef Cuts in Gravy Cat Food packed in 374 gm cans,
UPC 5574235301, Recall # V-120-2007;
15) CO-OP GOLD: Sliced Beef Dinner in Gravy Cat Food packed in 85 gm cans,
UPC 5731601064 and 156 gm cans, UPC 5731601068, Recall #
V-121-2007;
16) CO-OP GOLD: Sliced Chicken Beef Dinner in Gravy Cat Food packed in 156
gm
cans, UPC 5731601070, Recall # V-122-2007;
17) DEMOULAS MARKET BASKET: Flaked Tuna Dinner Cat Food packed in
3 oz cans, UPC 4970515356, Recall # V-123-2007;
18) DOCTORS FOSTER AND SMITH: Chicken Stew with Sweet Potatoes &
Carrots Cat Food packed in 5.5 oz cans, UPC 2514125280,
Recall # V-124-2007;
19) FAME: Sliced Chicken Dinner in Gravy Cat Food packed in 5.5 oz cans,
UPC 4540027074, Recall # V-125-2007;
20) FELINE CLASSIC: Flaked Tuna Dinner in Sauce Cat Food packed in 3 oz cans,
UPC 015080, Recall # V-126-2007;
21) FELINE CUISINE: Flaked Tuna Dinner in Sauce Cat Food packed in 3 oz cans,
UPC 014820, Recall # V-127-2007;
22) FELINE CUISINE: Sliced Chicken Dinner in Gravy Cat Food packed in 3 oz
cans,
UPC 014790, Recall # V-128-2007;
23) FELINE CUISINE: Sliced Beef Dinner in Gravy Cat Food packed in 3 oz cans,
UPC 014740, V-129-2007;
24) FOOD LION: Flaked Tuna Dinner Cat Food packed in 3 oz cans,
UPC 3582605986, Recall # V-130-2007;
25) GIANT COMPANION: Sliced Chicken Dinner in Gravy Cat Food
packed in 13.2 oz cans, UPC 8826700334, Recall # V-131-2007;
26) GIANT COMPANION: Flaked Tuna Dinner Cat Food packed in 3 oz cans,
UPC 8826700286, Recall # V-132-2007;
27) GIANT EAGLE: Flaked Tuna Entrée Cat Food packed in 3 oz cans,
UPC 3003402323, Recall # V-133-2007;
28) HANNAFORD: Flaked Trout Dinner Cat Food packed in 3 oz cans,
UPC 4126813537, Recall # V-134-2007;
29) HANNAFORD: Sliced Chicken Dinner in Gravy Cat Food packed in 5.5 oz cans,
UPC 4126812463, Recall # V-135-2007;
30) HILL COUNTRY FARE: Sliced Beef Dinner in Gravy Cat Food packed in 5.5
oz cans, UPC 4122063411, Recall # V-136-2007;
31) HY-VEE: Sliced Beef Dinner in Gravy Cat Food packed in 5.5 oz cans,
UPC 7545005640, Recall # V-137-2007;
32) HY-VEE: Sliced Chicken Dinner in Gravy Cat Food packed in 5.5 oz cans,
UPC 7545005639, Recall # V-138-2007;
37) LAGRIFFE: Sliced Chicken Dinner in Gravy Cat Food packed in 156 gm cans,
UPC 5974939750, Recall # V-139-2007;
34) LAGRIFFE: Sliced Beef Dinner in Gravy Cat Food packed in 85 gm cans,
UPC 5974939670, Recall # V-140-2007;
35) LAURA LYNN: Flaked Salmon & Ocean Whitefish Cat Food packed in 3 oz
cans,
UPC 8685403886, Recall # V-141-2007;
36) LAURA LYNN: Flaked Chicken & Tuna Cat Food packed in 3 oz cans,
UPC 8685403790, Recall # V-142-2007;
37) LAURA LYNN: Flaked Trout Cat Food packed in 3 oz cans, UPC 8685403788,
Recall # V-143-2007;
38) MASTER CHOICE: Sliced Beef Dinner in Gravy Cat Food packed in 85 gm cans,
UPC 6920045083 & 374 gm cans, UPC 6920045112, Recall
# V-144-2007;
39) MASTER CHOICE: Sliced Chicken Dinner in Gravy Cat Food packed in
374 gm cans, UPC 6920045121, Recall # V-145-2007;
40) MEIJER MAIN CHOICE: Sliced Beef Dinner in Gravy Cat Food packed in
3 oz cans, UPC 1928341174, Recall # V-146-2007;
41) MEIJER MAIN CHOICE: Variety Pack Dinner in Gravy Cat Food packed in
3 oz cans, UPC 1928341177, Recall # V-147-2007;
42) NATURAL ULTRAMIX: Chicken & Vegetables Dinner, Indoor Feline packed
in 3 oz cans, UPC 8087207961, Recall # V-148-2007;
43) NATURAL ULTRAMIX: Turkey & Vegetables Platter, Adult Feline packed
in 3 oz cans, UPC 8087207955, Recall # V-149-2007;
44) NATURAL ULTRAMIX: Salmon & Vegetables Entrée, Adult Feline packed
in
3 oz cans, UPC 8087207953, Recall # V-150-2007;
45) NATURAL ULTRAMIX: Chicken & Vegetables Casserole, Adult Feline packed
in 3 oz cans, UPC 8087207951, Recall # V-151-2007;
46) NUPET: Sliced Tuna Dinner Cat Food packed in 3 oz cans, UPC 1754412917,
Recall # V-152-2007;
47) NUPET: Sliced Chicken Dinner Cat Food packed in 5.5 oz cans,
UPC 1754411210, Recall # V-153-2007;
48) NUTRIPLAN: Flaked Tuna Dinner Cat Food packed in 3 oz cans,
UPC 4113006811, Recall # V-154-2007;
49) NUTRO NATURAL CHOICE: Tuna & Chicken Formula Kitten Food packed
in 3 oz cans, UPC 7910535204, Recall # V-155-2007;
50) NUTRO NATURAL CHOICE: Beef & Chicken Formula Kitten Food packed
in 3 oz cans, UPC 7910535203, Recall # V-156-2007;
51) NUTRO MAX CAT: Chicken & Ocean fish Formula Kitten Food packed in
3 oz cans, UPC 7910538101, Recall # V-157-2007;
52) PAWS: Sliced Chicken, Hearts & Liver Dinner Cat Food, packed in 3 oz
cans,
UPC 3680008691, Recall # V-158-2007;
53) PAWS: Sliced Beef Dinner in Gravy Cat Food, packed in 3 oz cans,
UPC 3680008248, Recall # V-159-2007;
54) PAWS: Tuna Dinner Cat Food, packed in 3 oz cans, UPC 3680008251,
Recall # V-160-2007;
55) PERFORMATRIN ULTRA: Chicken Stew Cat Food, packed in 5.5 oz cans,
UPC 015180, Recall # V-161-2007;
56) PET PRIDE: Sliced Chicken, Hearts & Liver Dinner Cat Food, packed in
3 oz cans, UPC 1111086261, Recall # V-162-2007;
57) DEMOULAS MARKET BASKET: Flaked Trout Dinner Cat Food packed in
3 oz cans, UPC 4970515361, Recall # V-163-2007;
58) PET PRIDE: Variety Pack Cat Food, packed in 3 oz cans, UPC 1111086003,
Recall # V-164-2007;
59) PET PRIDE: Shredded Turkey & Cheese Dinner Cat Food, packed in
5.5 oz cans, UPC 1111084878, Recall # V-165-2007;
60) PRESIDENT'S CHOICE: Chicken Cuts Dinner in Gravy Cat Food packed
in 374 gm cans, UPC 6038365965, Recall # V-166-2007;
61) PRESIDENT'S CHOICE: Beef in Gravy Cat Food packed in 156 gm cans,
UPC 6038365882, Recall # V-167-2007;
62) PRESIDENT'S CHOICE: Turkey in Gravy Cat Food packed in 85 gm cans,
UPC 6038337158, Recall # V-168-2007;
63) PRESIDENT'S CHOICE: Chicken in Gravy Cat Food packed in 85 gm cans,
UPC 6038337159, Recall # V-169-2007;
64) PRESIDENT'S CHOICE: Chicken & Turkey in Gravy Cat Food packed in 85
gm cans, UPC 6038367291, Recall # V-170-2007;
65) PRICE CHOPPER BEST FRIENDS: Flaked Tuna Dinner Cat Food packed in
3 oz cans, UPC 4173512826, Recall # V-171-2007;
66) PRIORITY: Flaked Tuna Dinner Cat Food packed in 3 oz cans,
UPC 2113041398, Recall # V-172-2007;
67) PRIORITY: Chunky Chicken Feast Cat Food packed in 3 oz cans,
UPC 2113041293, Recall # V-173-2007;
68) PRIORITY: Sliced Tuna Feast Cat Food packed in 3 oz cans,
UPC 2113041344, Recall # V-174-2007;
69) PRIORITY: Variety Pack Cat Food packed in 3 oz cans, UPC 2113041397,
Recall # V-175-2007;
70) ROCHE BROTHERS: Sliced Beef in Gravy Cat Food packed in 3 oz cans,
UPC 3963909711, Recall # V-176-2007;
71) ROUNDYS: Flaked Fish & Shrimp Dinner in Sauce Cat Food packed in
3 oz cans, UPC 1115078478, Recall # V-177-2007;
72) SCHNUCKS: Sliced Chicken in Gravy Cat Food packed in 5.5 oz cans,
UPC 4131807102, Recall # V-178-2007;
73) SCHNUCKS: Sliced Beef in Gravy Cat Food packed in 5.5 oz cans,
UPC 4131807099, Recall # V-179-2007;
74) SCHNUCKS: Sliced Tuna in Gravy Cat Food packed in 3 oz cans,
UPC 4131807087, Recall # V-180-2007;
75) SOPHISTACAT: Sliced Chicken in Gravy Cat Food packed in 5.5 oz cans,
UPC 3725701311, Recall # V-181-2007;
76) SOPHISTACAT: Sliced Turkey & Liver in Gravy Cat Food packed in
5.5 oz cans, UPC 3725701313, Recall # V-182-2007;
77) SOPHISTACAT: Tuna & Egg in Sauce Cat Food packed in 5.5 oz cans,
UPC 3725741106, Recall # V-183-2007;
78) SOPHISTACAT: Sliced Tuna Dinner in Sauce Cat Food packed in 5.5 oz cans,
UPC 3725701315, Recall # V-184-2007;
79) SOPHISTACAT: Tuna in Sauce Cat Food packed in 5.5 oz cans,
UPC 3725741107, Recall # V-185-2007;
80) SOPHISTACAT: Special Diet Sliced Chicken Dinner in Gravy Cat Food
packed in 5.5 oz cans, UPC 3725701309, Recall # V-186-2007;
81) SOPHISTACAT: Sliced Ocean Whitefish Dinner in Gravy Cat Food packed
in 5.5 oz cans, UPC 3725701314, Recall # V-187-2007;
82) SOPHISTACAT: Sliced Beef Dinner in Gravy Cat Food packed in 5.5 oz
cans, UPC 3725701312, Recall # V-188-2007;
83) SOPHISTACAT: Sliced Chicken & Salmon Dinner in Gravy Cat Food packed
in 5.5 oz cans, UPC 3725701316, Recall # V-189-2007;
84) SOPHISTACAT: Beef in Gravy Cat Food packed in 13.2 oz cans, UPC
3725701328, Recall # V-190-2007;
85) SOPHISTACAT: Chicken in Gravy Cat Food packed in 13.2 oz cans,
UPC 3725701327, Recall # V-191-2007;
86) SPECIAL KITTY: Sliced Beef Dinner in Gravy Cat Food packed in 5.5 oz
cans, UPC 7874264598, Recall # V-192-2007;
87) SPECIAL KITTY : Sliced Chicken Dinner in Gravy Cat Food packed in 5.5 oz
cans, UPC 7874264597, Recall # V-193-2007;
88) SPRINGFIELD PRIZE: Sliced Beef Dinner in Gravy Cat Food packed in 5.5 oz
cans, UPC 4138013806, Recall # V-194-2007;
89) TRIUMPH: Turkey & Giblets in Gravy Cat Food packed in 3 oz pouches,
UPC 7365700332, Recall # V-195-2007;
90) TRIUMPH: Mixed Grill in Gravy Cat Food packed in 3 oz pouches, UPC
7365700334, Recall # V-196-2007;
91)TRIUMPH: Sliced Beef in Gravy Cat Food packed in 3 oz pouches, UPC 7365700167,
Recall # V-197-2007;
92) WEGMANS: Sliced Beef in Gravy Cat Food packed in 3 oz cans,
UPC 7789076381, Recall # V-198-2007;
93) WESTERN FAMILY: Flaked Tuna Dinner Cat Food packed in 85 gm cans,
UPC 6263929254, Recall # V-199-2007;
94) White Rose: Shredded Turkey & Cheese Cat Food packed in 5.5 oz cans,
UPC 7480734377, Recall # V-200-2007;
95) WINN DIXIE: Flaked Tuna Entrée Cat Food packed in 3 oz cans, UPC
2441018632, Recall # V-201-2007;
96) YOUR PET: Flaked Tuna Dinner Cat Food packed in 3 oz cans, UPC 7203640010,
Recall # V-202-2007;
97) YOUR PET: Sliced Chicken, Hearts & Liver Dinner Cat Food packed in
3 oz cans,
UPC 7203629028, Recall # V-203-2007;
98) AUTHORITY: Lamb & Rice Formula Dog Food packed in 6 oz cans, UPC
3725736971, Recall # V-204-2007;
99) AUTHORITY: Lite Chicken & Rice Formula Dog Food packed in 14 oz cans,
UPC 3725712044, Recall # V-205-2007;
100) AWARD: Beef Casserole Dinner in Sauce Dog Food packed in 5.5 oz cans,
UPC 3725700504, Recall # V-206-2007;
101) AWARD: Chicken Casserole Dinner in Sauce Dog Food packed in 5.5 oz cans,
UPC 3725700502, Recall # V-207-2007;
102) AWARD: Sliced Chicken Dinner in Gravy Dog Food packed in 5.5 oz cans,
UPC 3725700432, Recall # V-208-2007;
103) AWARD: Sliced Beef Dinner in Gravy Dog Food packed in 5.5 oz cans,
UPC 3725700431, Recall # V-209-2007;
104) BEST CHOICE: Beef & Liver Dog Food packed in 13.2 oz cans, UPC 7003860079,
and 22 oz cans, UPC 7003860082,
Recall # V-210-2007;
105) BEST CHOICE: Beef Dog Food packed in 22 oz cans, UPC 7003860081,
Recall # V-211-2007;
106) BEST CHOICE : Chicken Dog Food packed in 22 oz cans, UPC 7003860085,
Recall # V-212-2007;
107) COMPLIMENTS: Beef Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 5574235307, and packed in 624
gm cans, UPC 5574235311, Recall # V-213-2007;
108) COMPLIMENTS: Chicken Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 5574235390, and packed
in 624 gm cans, UPC 5574235310, Recall # V-214-2007;
109) COMPLIMENTS: Country Stew Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 5574235387, Recall # V-215-2007;
110) COMPLIMENTS; Lamb & Vegetable Cuts in Gravy Dog Food packed in 624
gm cans,
UPC 5574235315, Recall # V-216-2007;
111) CO-OP GOLD: Beef Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 5731601075 and in 624 gm cans,
UPC 5731601080 Recall # V-217-2007;
112) CO-OP GOLD: Chicken Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 5731601077 and in 624 gm cans,
UPC 5731601081, Recall # V-218-2007;
113) CO-OP GOLD: Stew Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 5731601079 and in 624 gm cans,
UPC 5731601082, Recall # V-219-2007;
114) HANNAFORD: Chicken Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4126812292, Recall # V-220-2007;
115) HANNAFORD: Country Stew Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4126813533, Recall # V-221-2007;
116) HEALTH DIET GOURMET CUISINE: Beef Cuts in Gravy Dog Food packed in
156 gm cans, UPC 7819801515, & packed
in 374 gm cans, UPC 7819801519, and
624 gm cans, UPC 7819801524, Recall
# V-222-2007;
117) HEALTH DIET GOURMET CUISINE: Chicken Cuts in Gravy Dog Food packed in
624 gm cans, UPC 7819801527,
Recall # V-223-2007;
118) HEALTH DIET GOURMET CUISINE: Country Stew Cuts in Gravy Dog Food packed
in 624 gm cans, UPC 7819801529,
Recall # V-224-2007;
119) HILL COUNTRY FARE: BBQ w/ Beef Slices in Sauce Dog Food packed in 5.5
oz cans,
UPC 4122005168, Recall # V-225-2007;
120) HILL COUNTRY FARE: BBQ w/ Chicken Slices in Sauce Dog Food packed in 5.5
oz cans,
UPC 4122005169, Recall # V-226-2007;
121) HILL COUNTRY FARE: Chicken Slices in Gravy Dog Food packed in 5.5 oz cans,
UPC 4122068708, Recall # V-227-2007;
122) HILL COUNTRY FARE: Country Stew in Gravy Dog Food packed in 13.2 oz cans,
UPC 4122068712, and packed in 22
oz cans, UPC 4122067531, Recall # V-228-2007;
123) HILL COUNTRY FARE: Chicken Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4122068715, Recall # V-229-2007;
124) HILL COUNTRY FARE: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4122000864, Recall # V-230-2007;
125) HILL COUNTRY FARE: Lamb Cuts & Vegetables in Gravy Dog Food packed
in 22 oz cans,
UPC 4122067530, Recall # V-231-2007;
126) HILL COUNTRY FARE: BBQ Beef Cuts in Gravy Dog Food packed in 13.2 oz cans,
UPC 4122068711, Recall # V-232-2007;
127) HILL COUNTRY FARE: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4122068532, Recall # V-233-2007;
128) HY-VEE: Sliced Beef Dinner in Gravy Dog Food packed in 5.5 oz cans,
UPC 7545005546, Recall # V-234-2007,
129) HY-VEE: Sliced Chicken Dinner in Gravy Dog Food packed in 5.5 oz cans,
UPC 7545005561,
Recall # V-235-2007;
130) HY-VEE: Chicken Cuts in Gravy Dog Food packed in 13.2 oz cans, UPC 7545005606,
Recall # V-236-2007;
131) HY-VEE: Beef & Liver Cuts in Gravy Dog Food packed in 13.2 oz cans,
UPC 7545005604,
and 22 oz cans, UPC 7545005611,
Recall # V-237-2007;
132) HY-VEE: Stew Cuts in Gravy Dog Food packed in 13.2 oz cans, UPC 7545005572,
Recall # V-238-2007;
133) HY-VEE: Beef Cuts in Gravy Dog Food packed in 22 oz cans, UPC 7545005608,
Recall # V-239-2007;
134) LAGRIFFE: Chicken Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 5974939662, Recall # V-240-2007;
135) LAGRIFFE: Beef Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 5974939654, Recall #
V-241-2007;
136) MASTER CHOICE: Chicken Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 6920045163, and 624 gm cans,
UPC 6920045185, Recall # V-242-2007;
137) MASTER CHOICE: Beef Cuts in Gravy Dog Food packed 624 gm cans,
UPC 6920045182, Recall # V-243-2007;
138) MASTER CHOICE: Country Stew Cuts in Gravy Dog Food packed
624 gm cans, UPC 6920045187, Recall
# V-244-2007;
139) NATURAL LIFE: Adult Lamaderm Dog Food packed in 13.2 oz cans,
UPC 1234406144, Recall # V-245-2007;
140) NATURAL LIFE : Puppy Complete Dog Food packed in 13.2 oz cans,
UPC 1234401114, Recall # V-246-2007;
141) NUPET: Chicken Cuts in Gravy Dog Food packed in 5.5 oz cans, UPC 1754413153,
and 22 oz cans, UPC 7175441315,
Recall # V-248-2007;
142) NUPET: Beef Cuts in Gravy Dog Food packed in 22 oz cans, UPC 175412499,
Recall # V-248-2007;
143) NUPET: Country Stew Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 1754412501, Recall # V-249-2007;
144) NUPET: Lamb Cuts & Vegetables in Gravy Dog Food packed in 22 oz cans,
UPC 1754412922, Recall # V-250-2007;
145) OL’ ROY CANADA, Chicken Cuts in Gravy Dog Food packed in 374 gm
cans,
UPC 7874251411 & Value Pack
UPC 7874252011; and packed in 624 gm cans,
UPC 7874251388, Recall # V-251-2007;
146) OL’ ROY CANADA, Beef Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 7874251403 & Value Pack
UPC 7874252019, packed in 624 gm cans,
UPC 7874251435, Recall # V-252-2007;
147) OL’ ROY CANADA Country Stew Cuts in Gravy Dog Food packed in 374
gm cans,
UPC 7874264516, and packed in 624
gm cans, UPC 7874264520, Recall # V-253-2007;
148) OL’ ROY CANADA: Beef & Liver Cuts in Gravy Dog Food packed in
374 gm cans,
UPC 7874264515 and packed in 624
gm cans, UPC 7874264519, Recall # V-254-2007;
149) O’ ROY CANADA: Beef, Bacon & Cheese Cuts in Gravy Dog Food packed
in 624 gm cans, UPC 7874251433,
Recall # V-255-2007;
150) OL’ ROY CANADA: Beef Cuts & Barley in Gravy Dog Food packed
in 624 gm cans,
UPC 7874251425, Recall # V-256-2007;
151) OL’ ROY CANADA: Lamb & Vegetable Cuts in Gravy Dog Food packed
in 624 gm cans,
UPC 7874252132, Recall # V-257-2007;
152) PERFORMATRIN ULTRA: Chicken & Wild Rice Stew Dog Food, packed in 374
gm cans,
UPC 7819801776, Recall # V-258-2008;
153) PERFORMATRIN ULTRA: Lamb & Wild Rice Stew Dog Food, packed in 374
gm cans,
UPC 7819801775, Recall # V-259-2008;
154) PET PRIDE: Sliced Beef Dinner in Gravy Dog Food, packed in 5.5 oz cans,
UPC 1111086025, Recall # V-260-2007;
155) PET PRIDE: Beef & Liver Cuts in Gravy Dog Food, packed in 22 oz cans,
UPC 1111086232, Recall # V-261-2007;
156) PRESIDENT’S CHOICE: Beef Cuts in Gravy Dog Food packed in 156 gm
cans,
UPC 6038364168, 374 gm cans, UPC
6038337457; and 624 gm cans, UPC 6038337456,
Recall # V-262-2007;
157) PRESIDENT’S CHOICE: Chicken Cuts in Gravy Dog Food packed in 156
gm cans,
UPC 6038364167; 374 gm cans, UPC
6038337459; and 624 gm cans, UPC 6038337458,
Recall # V-263-2007;
158) PRESIDENTS CHOICE: Chicken and Veal Cuts in Gravy Dog Food packed in
624 gm cans, UPC 6038368762, Recall
# V-264-2007;
159) PRESIDENTS CHOICE: Beef Stew Cuts in Gravy Dog Food packed
in 624 gm cans, UPC 6038365895,
Recall # V-265-2007;
160) PRESIDENT’S CHOICE: Beef Cuts w/ Bacon & Cheese in Gravy Dog
Food
packed in 624 gm cans, UPC
6038367619, Recall # V-266-2007;
161) PRESIDENT’S CHOICE: Beef Cuts w/ Barley in Gravy Dog Food packed
in
624 gm cans, UPC 6038367620,
Recall # V-267-2007;
162) PRESIDENT’S CHOICE: Beef & Chicken Cuts in Gravy Dog Food packed
in
624 gm cans, UPC 6038367618, Recall
# V-268-2007;
163) PRIORITY: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 2113042017, Recall # V-269-2007;
164) PRIORITY: Chicken Cuts in Gravy Dog Food packed in 5.5 oz cans,
UPC 2113042007, Recall # V-270-2007;
165) SCHNUCKS: Sliced Turkey in Gravy Dog Food packed in 5.5 oz cans,
UPC 4131807108, Recall # V-271-2007;
166) SCHNUCKS: Chicken Cuts in Gravy Dog Food packed in 13.2 oz cans,
UPC 4131807121, Recall # V-272-2007;
167) SCHNUCKS: Beef & Liver Cuts in Gravy Dog Food packed in 13.2 oz cans,
UPC 4131807118, Recall # V-273-2007;
168) SCHNUCKS: Country Stew Cuts in Gravy Dog Food packed in 13.2 oz cans,
UPC 4131807123, Recall # V-274-2007;
169) SCHNUCKS: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4131807146, Recall # V-275-2007;
170) SCHNUCKS: Chopped Beef Dog Food packed in 22 oz cans, UPC 4131807147,
Recall # V-276-2007;
171) SPRINGFIELD PRIZE: Country Stew Cuts in Gravy Dog Food packed in 13.2
oz cans,
UPC 4138013908 and 22 oz cans, UPC
4138013907, Recall # V-277-2007;
172) SPRINGFIELD PRIZE: Lamb & Vegetable Cuts in Gravy Dog Food packed
in
22 oz cans, UPC 4138013891, Recall
# V-278-2007;
173) SPRINGFIELD PRIZE: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4138013890, Recall # V-279-2007;
174) Springfield Prize: Chicken Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 4138013904, Recall # V-280-2007;
175) Springfield Prize: Sliced Chicken in Gravy Dog Food packed in 5.5 oz cans,
UPC 4138014291, Recall # V-281-2007;
176) Stater Brothers: Sliced Beef in Gravy Dog Food packed in 5.5 oz cans,
UPC 7417512351, Recall # V-282-2007;
177) Stater Brothers: Beef Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 7417512282, Recall # V-283-2007;
178) Stater Brothers: Beef & Liver Cuts in Gravy Dog Food packed in 22
oz cans,
UPC 7417512359, Recall # V-284-2007;
179) Stater Brothers: Chicken Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 7417512280, Recall # V-285-2007;
180) Stater Brothers: Country Stew Cuts in Gravy Dog Food packed in 22 oz cans,
UPC 7417512283, Recall # V-286-2007;
181) Stater Brothers: Lamb & Vegetables Cuts in Gravy Dog Food packed
in 22 oz cans,
UPC 7417512357, Recall # V-287-2007;
182) TRIUMPH: Beef Cuts in Gravy Dog Food packed in 5.5 oz cans,
UPC 7365700171, Recall # V-288-2007;
183) TRULY: Beef & Liver Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 0036441665, Recall # V-289-2007;
184) TRULY: Beef Cuts in Gravy Dog Food packed in 624 gm cans, UPC 0036442036,
Recall # V-290-2007;
185) TRULY: Country Stew Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 0036441806, Recall # V-291-2007;
186) TRULY: Chicken Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 0036449564, Recall # V-292-2007;
187) WESTERN FAMILY: Chicken Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 6263919580, Recall # V-293-2007;
188) WESTERN FAMILY: Country Stew Cuts in Gravy Dog Food packed in 374 gm cans,
UPC 6263919579, and packed in 624
gm cans, UPC 6263919590, Recall # V-294-2007;
189) WESTERN FAMILY: Lamb and Vegetable Cuts in Gravy Dog Food packed in
624 gm cans, UPC 6263929264,
Recall # V-295-2007;
190) WESTERN FAMILY: Beef Cuts in Gravy Dog Food packed in 624 gm cans,
UPC 6263919587, Recall # V-296-2007;
191) WESTERN FAMILY: Beef & Liver Cuts in Gravy Dog Food packed in 624
gm cans,
UPC 6263919588, Recall # V-297-2007;
192) WESTERN FAMILY: Sliced Beef Dinner in Gravy packed in 5.5 oz cans,
UPC 1540005192, Recall # V-298-2007;
193) WESTERN FAMILY: Beef & Liver Cuts in Gravy packed in 13.2 oz cans,
UPC 1540004070, Recall # V-299-2007;
194) WESTERN FAMILY: Country Stew Cuts in Gravy packed in 13.2 oz cans,
UPC 1540004069, Recall # V-300-2007
CODE
Best By/Date Codes: Dec/06/09 to Jan/24/10;
Best By/Date Codes: Nov/08/08 to Mar/07/10;
Best By/Date Codes: Dec/11/09 to Mar/07/10;
RECALLING FIRM/MANUFACTURER
Menu Foods Midwest Corp., Emporia, KS, by telephone, fax, and e-mail beginning
on May 1, 2007, and by letters dated May 9, 2007. Firm initiated recall is
ongoing.
REASON
Menu Foods is recalling cuts and gravy style and select other products which
do not include ChemNutra wheat gluten but were manufactured at any of Menu
Foods' plants during the period that ChemNutra wheat gluten was used due to
the possibility of cross-contamination. Menu Foods has received a report from
a customer and has received study results, both of which indicate cross-contamination.
VOLUME OF PRODUCT IN COMMERCE
464,565 cases
DISTRIBUTION
Nationwide, Mexico and Canada
___________________________________
PRODUCT
Squirrel Corn Nuggets in 5 lb bags. The product is shipped in cases containing
6 bags, Recall # V-320-2007
CODE
7095JA best if used by 040509 and 7094JA best if used by 040409
RECALLING FIRM/MANUFACTURER
Recalling Firm: Brown’s F M Sons, Inc., Sinking Spring, PA, by telephone
on June 1, 2007.
Manufacturer: Zeigler Brothers, Inc., Gardners, PA. Firm initiated recall is
ongoing.
REASON
Binding agent (AquaBond) was recalled due to melamine.
VOLUME OF PRODUCT IN COMMERCE
207 bags
DISTRIBUTION
PA and VA
___________________________________
PRODUCT
a) Ginger brand Brine Shrimp Sinking Pellets, 2.2 ounce jars, Item/product code
#P956,
Recall # V-321-2007;
b) Ginger Brine Shrimp Sinking Pellets Item/product code P958. Product is packaged
in
4.5 ounce jars, Recall # V-322-2007;
c) Ginger Brine Shrimp Sinking Pellets, Item/product code P959. Product is packaged
in
11 ounce jars, Recall # V-323-2007;
d) Ginger Brine Shrimp Sinking Pellets, Item/product code BP959. Product is packaged
in
10 lb. bags, Recall # V-324-2007;
e) Discovery Pet Brands Sinking Pellets with Brine Shrimp, Item/product code
A2491.
Product is packaged in 2.2 ounce jars. Recall # V-325-2007;
f) Discovery Pet Brands Sinking Pellets with Brine Shrimp, Item/product code
A2492.
Product is packaged in 5.5 ounce jars, Recall # V-326-2007;
g) Earl May Brand Sinking Pellets with Brine Shrimp, Item A2492. Product is packaged
in
5.5 ounce jars. Product code: EM2492, Recall # V-327-2007
CODE
The product is identified with the product code.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ginger Inc., Toledo, OH, by letter on June 14, 2007.
Manufacturer: Tembec BTLSR, Inc., Toledo, OH. Firm initiated recall is ongoing.
REASON
Product contains melamine, an unapproved additive for animal and fish feed.
VOLUME OF PRODUCT IN COMMERCE
1,250 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) 25% Shrimp Feed, Net Weight 50lbs (25.00 kg), Recall # V-328-2007;
b) 30% Shrimp Feed, Net Weight 50lbs (25.00 kg), Recall # V-329-2007;
c) 35% Shrimp Feed, Net Weight 50lbs (25.00 kg), Recall # V-330-2007;
d) Bulk product, Recall # V-331-2007
CODE
a), b) and c) F160037;
d) None
RECALLING FIRM/MANUFACTURER
SouthFresh Feeds, Demopolis, AL, by telephone on May 31, 2007 and June 5, 2007.
Firm initiated recall is complete.
REASON
Products were manufactured using an aquatic binder which contains melamine, a
substance unapproved for use in animal and fish feeds.
VOLUME OF PRODUCT IN COMMERCE
233.9 tons
DISTRIBUTION
Belize and AL
___________________________________
PRODUCT
a) Xtra-Bond All Purpose Pellet Binder For Use In Animal Feeds, Ingredients:
Urea formaldehyde
condensation polymer and calcium sulfate, 50 Pounds, Recall
# V-357-2007;
b) Aqua-Tec II Pellet Binder for Fish, Shrimp & Animal Feeds, For Manufacturing
Use Only,
Ingredients: Polymethylolcarbamide, Sodium Sulfate, and Silicon
Dioxide, 25 kg.,
Recall # V-358-2007;
c) Aquabond-CM (Product No. 3941009083), A proprietary formula containing sodium
sulfate
and other nutritionally compatible binding agents, 25 KG,
Recall # V-359-2007
CODE
Any product manufactured after 01/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Uniscope, Inc., Johnstown, CO, by telephone on May 29, 2007 and
letter on May 31, 2007.
Manufacturer: Tembec BBTLSR, Inc., Toledo, OH. Firm initiated recall is ongoing.
REASON
Binding agents used in the manufacture of livestock and aquaculture feeds contain
melamine, an unapproved feed additive.
VOLUME OF PRODUCT IN COMMERCE
4,917,624 lbs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Shrimp Pellets, 1.6oz, 4.6oz and 9.1oz., For All Tropical Fish, UPC #'s 009112250006,
009112250013, 009112250020, Recall # V-360-2007;
b) African Cichlid Attack, Sinking Pellet Food, 3.8oz, 8.0oz and 28oz, for African
cichlids and
other bottom-feeding fish; UPC #'s 009112220016, 009112220085,
009112220092,
Recall # V-361-2007;
c) TOPFIN Shrimp Pellets, Granules de Crevette, Nutritious Sinking Treat for
Bottom
Feeders, 4.6oz and 9.1oz, UPC #'s 737257370197, 737257370180,
Recall # V-362-2007;
d) Goldfish Pellet Food Small Nibblets, sinking pellets, 3.6oz, 7.6oz and 25oz.,
UPC #'s 009112110133, 009112110249, 009112110157, Recall
# V-363-2007;
e) Goldfish Large Pellet Food, sinking pellets, 25oz., UPC #
009112110164, Recall # V-364-2007;
f) Oscar Bites, Micro pellet mix, 1oz, Oscar Grow, Medium Pellet Mix, 3.8oz,
Oscar Show,
Large Pellet Mix, 8oz, UPC #'s 009112110171, 009112110188,
009112110195, Recall # V-365-2007;
g) Baby Bites, Guppy & Fry Fish Food, 1.2oz, UPC #009112200070, Recall #
V-366-2007;
h) Crab & Lobster Bites Fast-Sinking Crustacean Food, 1.3oz, UPC #009112200025,
Recall # V-367-2007;
i) Goldfish Bites, Goldfish Small Pellet Food, 1.5oz, UPC # 009112110126,
Recall # V-368-2007
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
HBH Enterprises, Springville, UT, by letter on June 8, 2007. Firm initiated recall
is ongoing.
REASON
Shrimp pellets made from recalled melamine containing aquaculture product were
used in the manufacture of various ornamental fish foods.
VOLUME OF PRODUCT IN COMMERCE
165,740 lbs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Bulk MoorMan's Beef Trate-RU-150, 470AD, Medicated, A Supplement for Beef
Replacement
Heifers and Beef Cattle, containing 600 gm/ton Monensin, Recall
# V-369-2007;
b) Bulk ADM Alliance Nutrition GroFast Step 2, 34629NKS, Medicated, A Supplement
for
Growing Calves, containing 114.3 gm/ton Monensin, Recall #
V-370-2007;
c) Bulk ADM Alliance Nutrition GroFast Soybean Balancer, 34717CCP, Medicated,
A Supplement for Beef Cattle Fed in Confinement, containing
400 gm/ton Monensin,
Recall # V-371-2007;
d) MoorMan's Expeditor Dairy Beef RU/TY Medicated, product #573AB, A Supplement
for
Dairy Beef Cattle Fed In Confinement for Slaughter, packaged
in 50-lb. bags, containing
400 gm/ton Monensin and 180 gm/ton Tylosin, Recall # V-372-2007
CODE
a) Batches 40912, 40835, 40639, 40575, 40233, 40100, and 39998;
b) Batches 41015, 40904, 40820, 40636, 40517, 40173, and 40037;
c) Batches 41018, 40804, 40767, 40512, 40393, 40247, 40030, 40224, 40348, and
41087;
d) Batches 39993 and 41090
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADM Alliance Nutrition, Inc., Quincy, IL, by telephone and/or
visits on June 12, 2007 and by follow-up letters dated between June 18, 2007
and June 27, 2007.
Manufacturer: ADM Alliance Nutrition Inc, Le Mars, IA. Firm initiated recall
is complete.
REASON
Binder used in the manufacture of the premixes contained melamine.
VOLUME OF PRODUCT IN COMMERCE
90.65 tons bulk and 478/50-lb. bags
DISTRIBUTION
SD, IA, and MN
___________________________________
PRODUCT
a) Bulk ADM Alliance Nutrition Self Feeder 40/15, 51361BIU20, Medicated, A Supplement
for
Cattle in Confinement for Slaughter, containing 330 gm/ton
Lasalocid, Recall # V-373-2007;
b) Bulk ADM Alliance Nutrition Superlean 26, 50252AAA, Medicated, A Supplement
for
Feedlot Beef Cattle. (NOTE: The label indicates the product
is medicated, but no drug is
listed--This label has been determined by ADM to be incorrect
and does not contain any
medication.) , Recall # V-374-2007
CODE
a) Batches 58210, 59336, 60027, 60699, and 61495;
b) Batch 59310
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADM Alliance Nutrition, Inc., Quincy, IL, by telephone
and/or visits on June 12, 2007 and letters dated June 18, 2007.
Manufacturer: ADM Alliance Nutrition Inc., South Sioux City, NB. Firm initiated
recall is complete.
REASON
Binder used in the manufacture of the premixes contained melamine.
VOLUME OF PRODUCT IN COMMERCE
18 tons bulk
DISTRIBUTION
NE and SD
___________________________________
PRODUCT
a) Aquaculture feeds labeled as being manufactured by Rangen, Buhl, ID.
Products are sold in 25 lb. bags, 50 lb. bags or sold in bulk.
Bulk ranges
from 1 Ton to 22 Tons. 400 Sink:
Item 5000 EXTR 400 SINK 3/16 4.8mm in 50 lb. bag;
Item 4981EXTR 400 8mm in 50 lb. bag;
Item 4980 EXTR 400 SINK 8mm sold in bulk;
Item 4959 EXTR 400 SLOW SINK 1/8 3.3mm in 50 lb. bag;
Item 4974 EXTR 400 SINK 3/32 2.4mm in 50 lb. bag;
Item 4975 EXTR 400 SLOW SINK 3/32 2.4mm in 50 lb. bag;
Item 5579 EXTR 400 SLOW SINK 3/32 2.4mm in 50 lb. bag;
Item 4964 EXTR 400 SLOW SINK 3/8 9.5mm in 50 lb. bag;
Item 4978 EXTR 400 SLOW SINK 5/32 4.0mm in 50 lb. bag;
Item 4976 EXTR 400 SINK 5/32 4.0mm in 50 lb. bag;
Item 4977 EXTR 400 SINK 5/32 4.0mm sold in bulk;
Item 4958 EXTR 400 SINK 1/8 3.2mm in 50 lb. bag;
Item 4949 EXTR 400 SINK 1/4 6.4mm sold in bulk;
Item 5001 EXTR 400 SINK 3/16 4.8mm sold in bulk;
Item 4961 EXTR 400 SLOW SINK 3/8 9.5mm sold in bulk,
Recall # V-375-2007;
b) 45/11 Brood w/Red & XXVits:
Item 5123 FISH FEED 45-11 Broodstock 1/2 12.7mm in 50 lb.
bag;
Item 5652 FISH FEED 45-11 Broodstock 1/8 3.2mm in 50 lb. bag;
Item 5120 FISH FEED 45-11 Broodstock 3/16 4.8mm in 50 lb.
bag;
Item 5122 FISH FEED 45-11 Broodstock 3/8 9.5mm in 50 lb. bag;
Item 5121 FISH FEED 45-11 Broodstock 1/4 6.4mm in 50 lb. bag,
Recall # V-376-2007;
c) 45/20: Item 5905 EXTR 45/20 1/8 3.2mm sold in bulk;
Item 5907 EXTR 45/20 3/16 4.8mm sold in bulk;
Item 5906 EXTR 45/20 5/32 4.0mm sold in bulk;
Item 5624 EXTR High Performance POULTRY 45/20 3/16 4.8mm in
50 lb. bag;
Item 5902 EXTR High Performance POULTRY 45/20 3/16 4.8mm in
50 lb. bag;
Item 5332 EXTR Hi-PERFORMANCE 45/21 3/16 4.8mm in 50 lb. bag;
Item 5523 EXTR Hi-PERFORMANCE 45/21 1/4 6.4mm in 50 lb. bag;
Item 5515 EXTR Hi-PERFORMANCE 45/21 1/8 3.2mm in 50 lb. bag;
Item 5331 EXTR Hi-PERFORMANCE 45/21 5/32 4.0mm in 50 lb. bag,
Recall # V-377-2007;
d) 45/25 Poultry: Item 5575 High Perf. 45/25 "POULTRY" 3/16 4.8mm in
50 lb. bag;
Item 5577 High Perf. 45/25 "POULTRY" 3/16 4.8mm
in 50 lb. bag,
Recall # V-378-2007;
e) 45/25 Sinking: Item 5546 EXTR High Performance 45/25 1/4 6.4mm in 50 lb. bag;
5460 EXTR Hi-Performance 45/25 3/16 4.8mm in 50 lb. bag;
Item 5233 EXTR High Performance 45/25 5/32 4.0mm in 50 lb.
bag;
Item 5526 EXT High Performance 45/25 1/8 3.2mm in 50 lb. bag;
Item 5517 EXTR High Performance 45/25 1/4 6.4mm in 50 lb.
bag;
Item 5513 EXTR High Performance 45/25 5/32 4.0mm in 50 lb.
bag;
Item 5634 EXTR High Performance 45/25 3/16 4.8mm in 50 lb.
bag;
Item 5576 EXTR High Performance 45/25 3/16 4.8mm in 50 lb.
bag;
Item 5232 EXTR High Performance 45/25 5/32 4.0mm sold in bulk;
Item 5516 EXTR High Performance 45/25 1/4 6.4mm sold
in bulk,
Recall # V-379-2007;
f) 450 Low Phos: Item 5393 EXTR LOW PHOSPHORUS TROUT 3.0mm in 50 lb. bag;
Item 5388 EXTR LOW PHOSPHORUS TROUT 2.0mm in 50 lb. bag;
Item 5395 EXTR LOW PHOSPHORUS TROUT 5.0mm in 50 lb. bag;
Item 5394 EXTR LOW PHOSPHORUS TROUT 4.0mm in 50 lb. bag,
Recall # V-380-2007;
g) 450 Sinking: Item 4861 EXTR 450 MISCELLANEOUS in 50 lb. bag;
Item 5129 EXTR 450 SLOW SINK 1/8 3.2mm in 50 lb. bag;
Item 5133 EXTR 450 SINKING 1/8 3.2mm in 50 lb. bag;
Item 5480 EXTR High Performance POULTRY 45/20 4.8mm in 50
lb. bag;
Item 5100 EXTR 450 SINK 3/16 4.8mm in 50 lb. bag;
Item 5130 EXTR 450 SINKING 3/32 2.4mm in 50 lb. bag;
Item 5102 EXTR 450 SINKING 5/32 4.0mm in 50 lb. bag
Recall # V-381-2007;
h) 470 Sink: Item 4772 EXSL 440 3/32 2.4mm in 50 lb. bag;
Item 4705 EXSL 470 SINKING 1/8 3.2mm in 50 lb. bag;
Item 4704 EXSL 470 SINKING 1/8 3.2mm sold in bulk;
Item 4752 EXSL 470 SLOW SINKING 1/8 3.2mm in 50 lb. bag;
Item 4625 EXSL 470 SLOW SINK 2.00mm in 50 lb. bag;
Item 4624 EXSL 470 SLOW SINK 2.00mm sold in bulk;
Item 4706 EXSL 470 SLOW SINK 3/32 2.4mm in 50 lb. bag;
Item 4707 EXSL 470 SLOW SINK 3/32 2.4mm sold in bulk;
Item 4864 EXSL 470 SINKING w / XX Vit 2.00mm sold in bulk,
Recall # V-382-2007;
i) Abernathy Crumbles & Pellets:
Item 4681 Abernathy A2-2 (92) Salmon Granules 3/64 in 50 lb.
bag;
Item 4682 Abernathy A2-2 (92) Salmon Granules 4/64 in 50 lb.
bag;
Item 4684 Abernathy A3-2 (92) Salmon Pellets 6/64 in 50 lb.
bag;
Item 4685 Abernathy A3-2 (92) Salmon Pellets 8/64 in 50 lb.
bag,
Recall # V-383-2007;
j) Custom Trout Crumbles/Starter: Item 4760 Custom Trout #0 in 50 lb. bag;
Item 4761 Custom Trout #1 in 50 lb. bag;
Item 4762 Custom Trout #2 in 50 lb. bag;
Item 5399 Custom Trout w/ xxvit #2 in 50 lb. bag;
Item 5400 Custom Trout Crumbles w/xxvit #3 in 50 lb. bag;
Item 4763 Custom Trout Crumbles #3 in 50 lb. bag;
Item 5401 Custom Trout Crumbles w/xxvit #4 in 50 lb. bag;
Item 4764 Custom Trout Crumbles #4 in 50 lb. bag;
Item 4722 Custom Trout Crumbles #4 sold in bulk;
Item 5056 Custom Trout Crumbles 42-13 #4 in 50 lb. bag,
Recall # V-384-2007;
k) EXTR Sinking Brood: Item 4727 Trout Broodstock With 150g Red 1/4 6.4mm in
50 lb. bag;
Item 4535 Trout Broodstock w/150g Red Slow Sink 1/4 6.4mm
in 50 lb. bag,
Recall # V-385-2007;
l) Medicated: Item 4788 MEDICATED FISH FEED 1/8 3.2mm in 50 lb. bag;
Item 4832 MEDICATED FISH FEED 1/8 3.2mm in 50 lb. bag;
Item 4785 MEDICATED FISH FEED 3/32 2.4mm in 50 lb. bag;
Item 4884 MEDICATED FISH FEED 3/32 2.4mm in 50 lb. bag;
Item 4850 MEDICATED FISH FEED 3/32 4.0mm in 50 lb. bag;
Item 4835 MEDICATED FISH FEED 5/32 4.0mm in 50 lb. bag;
Item 4791 MEDICATED FISH FEED 5/32 4.0mm in 50 lb. bag;
Item 4831 MEDICATED FISH FEED 5/32 4.0mm in 50 lb. bag;
Item 4834 MEDICATED FISH FEED # 2 in 50 lb. bag;
Item 4775 MEDICATED FISH FEED #1 in 50 lb. bag;
Item 4777 MEDICATED FISH FEED #2 in 50 lb. bag;
Item 4779 MEDICATED FISH FEED #3 in 50 lb. bag;
Item 4830 MEDICATED FISH FEED #3 in 50 lb. bag;
Item 4781 MEDICATED FISH FEED #4 in 50 lb. bag;
Item 4833 MEDICATED FISH FEED #4 in 50 lb. bag,
Recall # V-386-2007;
m) Salmon Brood Sinking: Item 4836 Salmon Broodstock w/ 150g Red 1/4 6.4mm in
50 lb. bag,
Recall # V-387-2007;
n) Salmon Grower Crum & Pellets: Item 1681 Salmon Grower No. 3 in 50 lb.
bag;
Item 1675 Salmon Grower No. 4 in 50 lb. bag;
Item 1674 Salmon Grower No. 4 sold in bulk;
Item 2493 Salmon Grower 1/4 6.4mm sold in bulk;
Item 1705 Salmon Grower 1/8 3.2mm in 50 lb. bag;
Item 1695 Salmon Grower 3/32 2.4mm in 50 lb. bag;
Item 1694 Salmon Grower 3/32 2.4mm sold in bulk,
Recall # V-388-2007;
o) Seasticks: Item 4965 CUSTOM SEA STICKS 3/32in 2.4mm in 50 lb. bag,
Recall # V-389-2007;
p) Shrimp 30%, 35%, 40%: Item 4750 MEDICATED SHRIMP FEED 3/32 in 50 lb. bag;
Item 5531 MEDICATED SHRIMP FEED 3/32 2.4mm in 50 lb. bag;
Item 2513 Shrimp Production 3/32 2.4mm in 50 lb. bag;
Item 5712 Shrimp Production 35/2.5 # 2 in 50 lb. bag;
Item 2497 Shrimp Production 35/2.5 #3 in 50 lb. bag;
Item 5456 KimCo Crumbles #1 in 50 lb. bag;
Item 4815 KimCo Crumbles #3 in 50 lb. bag;
Item 2518 MEDICATED SHRIMP FEED 3/32 2.4mm 30% sold in bulk;
Item 5628 SHRIMP PRODUCTION 40/5 3/32 2.4mm in 50 lb. bag;
Item 4986 SHRIMP PRODUCTION 40/0 3 in 50 lb. bag;
Item 2511 SHRIMP RODUCTION 40/5 3/32 2.4mm in 50 lb. bag;
Item 4817 SHRIMP PRODUCTION 40/5 #1 in 50 lb. bag;
Item 4818 SHRIMP PRODUCTION 40/5 #2 in 50 lb. bag;
Item 4819 SHRIMP PRODUCTION 40/5 #3 in 50 lb. bag;
Item 4745 SHRIMP PRODUCTION 40/5 #4 in 50 lb. bag;
Item 4816 SHRIMP PRODUCTION 40/5 #0 in 50 lb. bag;
Item 5605 SHRIMP PL 40-9: V-PAK BLEND #2 & #3 in 50 lb.
bag;
Item 5604 SHRIMP PL 40-9: V-PAK BLEND #1 & #2 in 50 lb.
bag,
Recall # V-390-2007;
q) Shrimp 45%: Item 2508 Shrimp Production 45/10 3/32 2.4mm in 50 lb. bag;
Item 2498 Shrimp Production 45/10 No. 0 in 50 lb. bag;
Item 2500 Shrimp Production 45/10 No. 1 in 50 lb. bag;
Item 2502 Shrimp Production 45/10 No.2 in 50 lb. bag;
Item 2504 Shrimp Production 45/10 No.3 in 50 lb. bag;
Item 2506 Shrimp Production 45/10 No.4 in 50 lb. bag;
Item 4999 Shrimp Production 45/10 3/32 in 50 lb. bag,
Recall # V-391-2007;
r) Shrimp 50%: Item 2451 Shrimp Maturation Feed 3/32 2.4mm in 50 lb. bag;
Item 5298 Shrimp Production 50/15 3/32 2.4mm in 50 lb. bag;
Item 5209 Shrimp Production 50/15 3/32 2.4mm in 50 lb. bag,
Recall # V-392-2007;
s) Shrimp w/o TAP: Item 5549 Shrimp Production 35/2.5 w/o TAP 3/32 2.4mm in 50
lb. bag;
Item 5606 SHRIMP PROD 40/5 w/o TAP # 2 in 50 lb. bag;
Item 4971 SHRIMP PROD 40/5 w/o TAP 3/32 2.4mm in 50 lb. bag;
Item 5542 SHRIMP PROD 40/5 w/o TAP # 4 in 50 lb. bag,
Recall # V-393-2007;
t) Starter: Item 1530 STARTER #0 Granules in 50 lb. bag;
Item 5087 STARTER #00 in 50 lb. bag;
Item 1538 STARTER #1 Granules in 50 lb. bag;
Item 1545 STARTER #2 Granules in 50 lb. bag;
Item 1552 STARTER #3 in 50 lb. bag;
Item 4543 STARTER w/o TAP 3/16 4.8mm in 50 lb. bag,
Recall # V-394-2007;
u) Starter - Aquamax: Item 4910 AQUAMAX FRY STARTER 100 in 50 lb. bag,
Recall # V-395-2007;
v) Starter - Fast Start: Item 1540 FAST START with Krill No.0 in 50 lb. bag;
Item 2399 FAST START with Krill No.1 in 50 lb. bag;
Item 5484 FAST START with Krill No.2 in 50 lb. bag;
Item 2405 FAST START with Krill No.3 in 50 lb. bag,
Recall # V-396-2007;
w) Starter - w/o TAP: Item 1546 STARTER w/o TAP # 0 in 50 lb. bag;
Item 1598 STARTER w/o TAP # 1 in 50 lb. bag;
Item 2402 STARTER w/o TAP # 2 in 50 lb. bag;
Item 2403 STARTER w/o TAP # 3 in 50 lb. bag;
Item 1567 STARTER w/o TAP # 4 in 50 lb. bag,
Recall # V-397-2007;
x) Steelhead Sinking WA Pelleted:
Item 5709 SINKING STEELHEAD PELLETS 1/8 3.2mm in 25 lb. bag;
Item 5245 SINKING STEELHEAD PELLETS 1/8 3.2mm in 25 lb. bag;
Item 5244 SINKING STEELHEAD PELLETS 3/32 2.4mm in 50 lb. bag;
Item 5328 SINKING STEELHEAD PELLETS 5/32 4.0mm in 50 lb. bag,
Recall # V-398-2007;
y) Trout Grower w/Avian: Item 5757 Trout Grower w/ avian blood No.2 in 50 lb.
bag;
Item 5758 Trout Grower w/ avian blood No.3 in 50 lb. bag;
Item 5759 Trout Grower w/ avian blood No.4 in 50 lb. bag,
Recall # V-399-2007;
z) Trout Grower: Item 1553 TROUT GROWER No.3 in 50 lb. bag;
Item 1560 TROUT GROWER # 4 in 50 lb. bag;
Item 1559 Trout Grower No.4 sold in bulk,
Recall # V-400-2007;
aa) Trout Production: Item 1616 TROUT PRODUCTION 1/4 6.4mm in 50 lb. bag;
Item 4509 Trout Production w/o tap 1/4 6.4mm in 50 lb. bag;
Item 1620 Trout Production w/ 1# Red 1/4 6.4mm in 50 lb. bag;
Item 1615 Trout Production 1/4 6.4mm sold in bulk;
Item 1592 TROUT PRODUCTION 1/8 3.2mm in 50 lb. bag;
Item 2406 Trout Production w/o tap 1/8 3.2mm in 50 lb. bag;
Item 1584 TROUT PRODUCTION 3/32 2.4mm in 50 lb. bag;
Item 1594 Trout Production 3/8 9.5mm in 50 lb. bag;
Item 1601 Trout Production 3/8 9.5mm sold in bulk;
Item 1600 TROUT PRODUCTION 5/32 4.0mm in 50 lb. bag;
Item 1604 Trout Production w/ 1 # RED 5/32 4.0mm in 50 lb.
bag;
Item 1655 Trout Broodstock 1/4 6.4mm in 50 lb. bag,
Recall # V-401-2007
CODE
a) thru o) and t) thru aa) Products are coded with the numerical date of
manufacture 5/26/06
through
5/26/07,
p) thru s) Products are coded with a letter designating the month: May = N, June
= E, July = A,
August
= T, September = D, October = V, November = P, December = J, January = K,
February
= B, March = C, April = L; the year 2006 = I, 2007 = Q
RECALLING FIRM/MANUFACTURER
Rangen, Inc., Buhl, ID, by letters on May 31, 2007 and June 12, 2007. Firm initiated
recall is ongoing.
REASON
Firm received binder (Aqua Tec II) that was contaminated with melamine (unapproved
feed additive) from another manufacturer and subsequently used that binder in
the manufacture of their finished products.
VOLUME OF PRODUCT IN COMMERCE
10,841,077 lbs. total of various feeds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Rangen, Inc., Extr 42/15 sink, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-402-2007;
b) Rangen, Inc., Extr 420 sink, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-403-2007;
c) Rangen, Inc., Trout & Salmon, custom aquaculture feed, 25 lb. bags, 50
lb. bags and bulk,
Recall # V-404-2007;
d) Rangen, Inc., Shrimp 40/5, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall # V-405-2007;
e) Rangen, Inc., Shrimp 45/10, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall V-406-2007;
f) Rangen, Inc., Shrimp 35/0, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall V-407-2007;
g) Rangen, Inc., Shrimp 35/2.5, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall V-408-2007;
h) Rangen, Inc., Shrimp 35/0 Mash, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-409-2007;
i) Rangen, Inc., Shrimp 30/0, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall # V-410-2007;
j) Rangen, Inc., Shrimp 35/0 SC, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-411-2007;
k) Rangen, Inc., Shrimp 30/0 SC, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-412-2007;
l) Rangen, Inc., Shrimp 35/2.5 SC, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-413-2007;
m) Rangen, Inc., Shrimp 35/0 short short cut, custom aquaculture feed, 25 lb.
bags,
50 lb. bags and bulk, Recall # V-414-2007;
n) Rangen, Inc., Shrimp 40/0, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall # V-415-2007;
o) Rangen, Inc., Shrimp 40/0 short SC, custom aquaculture feed, 25 lb. bags,
50 lb. bags and bulk,
Recall # V-416-2007;
p) Rangen, Inc., Extr 4413 sink, custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-417-2007;
q) Rangen, Inc., PR32 (sinking), custom aquaculture feed, 25 lb. bags, 50 lb.
bags and bulk,
Recall # V-418-2007;
r) Rangen, Inc., Trout Grower, custom aquaculture feed, 25 lb. bags, 50 lb. bags
and bulk,
Recall # V-419-2007
CODE
All feeds manufactured between May 26, 2006 and May 26, 2007
RECALLING FIRM/MANUFACTURER
Rangen, Inc., Angleton, TX, by letter on June 12, 2007. Firm initiated recall
is ongoing.
REASON
Fish feeds manufactured using ingredient contaminated with melamine and its analogs.
VOLUME OF PRODUCT IN COMMERCE
10,729,420 pounds
DISTRIBUTION
AR, CA, MS, KY, TX, CO, AL, VA, AZ, OK, MN, LA, MO, and FL
END OF ENFORCEMENT REPORT FOR OCTOBER 3, 2007
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