Enforcement Report

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.

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February 16, 2005
05-07

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
White Fungus, Net Wt. 5 oz. (142g 0.5g). Product of China. Barcode # 8 37385 00139 7. Recall # F-178-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
New Land Trading, Inc., Brooklyn, NY, by Consumer Alert and letter on October 29, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (1979 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
62 cases (50 -- 5 oz. packages per case).
DISTRIBUTION
NY.

_______________________________
PRODUCT
La Hacienda Tortilleria, 10" Flour Tortillas, in retail size packages, 1 dozen large burrito size, 12 per case. Recall # F-180-5.
CODE
Codes 090304 through 111604.
RECALLING FIRM/MANUFACTURER
La Hacienda Tortilleria, Inc. Nashville, TN, by telephone beginning on November 17, 2004. Firm initiated recall is complete.
REASON
The product bears an ingredient statement that fails to reveal the presence of whey, an allergen.
VOLUME OF PRODUCT IN COMMERCE
3,200 cases that were being distributed included this product and bulk Flour Tortillas (F-179-5 listed under Class II).
DISTRIBUTION
TN, AL, and KY.

_______________________________
PRODUCT
Red Diamond brand dried Chinese vegetable, net wt 3 oz (85g). Product of China. Barcode # 6 86529 13037 6. Recall # F-186-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Starway, Inc., Brooklyn, NY, by press release on December 23, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites(250 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
500 -- 3 oz. packages.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Flour Tortillas, bulk, wholesale packaging, 12 tortillas per wrapper, 24 packs per case. Recall # F-179-5.
CODE
Codes 090304 through 111604.
RECALLING FIRM/MANUFACTURER
La Hacienda Tortilleria, Inc. Nashville, TN, by telephone beginning on November 17, 2004. Firm initiated recall is complete.
REASON
This product does not bear any ingredient statement and contains whey as one of the ingredients.
VOLUME OF PRODUCT IN COMMERCE
3,200 cases that were being distributed included this product and 10" Flour Tortillas (F-180-5 listed under Class I).
DISTRIBUTION
TN, AL, and KY.

_______________________________
PRODUCT
a) Kilikia brand Cherry Soft Drink in 11.16 oz.
bottles. Recall # F-181-5;
b) Kilikia brand Orange Soft Drink in 11.16 oz.
bottles. Recall # F-182-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Kradjian Importing Co., Glendale, CA, by letter dated November 10, 2004. Firm initiated recall is ongoing.
REASON
a) The New York State Department of Agriculture and
Market's analysis found that the product contained
nonpermitted colors Ponceau 4R and carmoisine.
Additionally, the product contained aspartame but
failed to bear the statement "Phenylketonurics:
Contains phenylalanine";
b) The New York State Department of Agriculture and
Market's analysis found that the product contained
uncertified colors - tartrazine (certifiable as
FD&C Yellow No. 5) and sunset yellow FCF
(Certifiable as FD&C Yellow No. 6).
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Dragon Selected Food brand Dried Cassava Diced,
net. Wt. 7 oz. (200gr). Product of Vietnam.
The product is packed in a heat-sealed plastic bag.
Recall # F-183-5;
b) Dragon Selected Food brand Dried Cassava Sticks,
net. Wt. 7 oz. (200gr). Product of Vietnam.
The product is packed in a heat-sealed plastic bag.
Recall # F-184-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Sincere Trading LLC, Brooklyn, NY, by telephone, fax and letter dated January 12, 2005. Firm initiated recall is ongoing.
REASON
State of Florida's sampling & analysis of the product revealed the presence of unapproved and possible uncertified color additives -- tartrazine (certifiable as FD&C Yellow No. 5), allura red AC (certifiable as FD&C Red No. 40), Brilliant Blue FCF (certifiable as FD&C Blue No. 1) External D&C Red 10, and FD&C Red No 1.
VOLUME OF PRODUCT IN COMMERCE
4,350-200g packages.
DISTRIBUTION
NY, MA, CT, FL, GA, MI, OH, and PA.

_______________________________
PRODUCT
Sanapac's Vee 200 for Men. The product is sold in 90 cc and 120 cc bottles of 30 and 50 tablets and shipped in cases containing 12 bottles. Recall # F-185-5.
CODE
Lot numbers 1099, 7021, 0281, 0254, 0303, and 0491.
RECALLING FIRM/MANUFACTURER
Sanapac Co., Dallas, PA, by letter dated January 12, 2005. Firm initiated recall is ongoing.
REASON
The product is adulterated since it contains the new dietary ingredient, androstenedione, for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
VOLUME OF PRODUCT IN COMMERCE
288 bottles.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Gabriela Brand Rice Cracker Mix, 8 oz. --
Party Mix. Recall # F-187-5;
b) Gabriela Brand Rice Cracker Mix, 8 oz. --
Wasabi Variety. Recall # F-188-5;
c) Gabriela Brand Rice Cracker Mix, 8 oz. --
Hot and Spicy. Recall # F-189-5.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Barrington Trading, Bell, CA, by letter on January 19, 2005. Firm initiated recall is ongoing.
REASON
a) The product contains unapproved color additives --
amaranth (formerly certifiable as FD&C Red No. 2),
tartrazine (certifiable as FD&C Yellow No. 5), and
sunset yellow FCF (certifiable as FD&C Yellow No.
6);
b) The product contains unapproved color additives --
amaranth, tartrazine, sunset yellow FCF, and
brilliant blue FCF (certifiable as FD&C Blue No. 1);
c) The product contains an unapproved color additive --
Amaranth.
VOLUME OF PRODUCT IN COMMERCE
a) 770 cartons;
b) 336 cartons;
c) 671 cartons.
DISTRIBUTION
CA, FL, and Mexico.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Lunds Party Mint Ice Cream with red and green mint flavored flakes in mint flavored ice cream in half-gallon round paper containers with lid. Recall # F-190-5.
CODE
Code 27142 is found on plastic rim of the lid.
RECALLING FIRM/MANUFACTURER
Kemps, LLC, Minneapolis, MN, by e-mail and telephone on December 27, 2004 and by visit on December 28, 2004. Firm initiated recall is ongoing.
REASON
Lunds Party Mint Ice Cream in half-gallon containers, due to possibility of plastic pieces about 1/25" in size, found in the product.
VOLUME OF PRODUCT IN COMMERCE
1,428 half-gallon units.
DISTRIBUTION
MN.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Lupron Depot Injection (leuprolide acetate for
depot suspension) 7.5mg, Single Dose
Administration Kit with prefilled dual-chamber
syringe, IM injection, Rx Only, Kit includes:
One prefilled dual chamber syringe containing
needle with LuproLoc safety device and plunger.
NDC 0300-3642-01. Recall # D-117-5;
b) Lupron Depot Injection (leuprolide acetate for
depot suspension), 4 Month 30mg, Single Dose
Administration Kit with prefilled dual-chamber
syringe, IM injection, Rx Only, Kit includes:
One prefilled dual chamber syringe containing
needle with LuproLoc safety device and one plunger.
NDC 0300-3683-01. Recall # D-118-5.
CODE
a) Lot 20119AP21;
b) Lot 20117AP21.
RECALLING FIRM/MANUFACTURER
Tap Pharmaceutical Prod, Lake Forest, IL, by letters dated January 10, 2005. Firm initiated recall is ongoing.
REASON
Subpotent; clumping of the powdered medication in the diluent may interfere with delivery of the full therapeutic dose.
VOLUME OF PRODUCT IN COMMERCE
16,275 syringes.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Ciprofloxacin hydrochloride 3.5 mg equivalent to 3 mg base; Rx only, sterile ophthalmic solution for topical ophthalmic use only in 5 mL plastic dispenser bottle, 10 bottles per shelf pack. NDC 60505-1000-1. Recall # D-120-5.
CODE
Lot numbers GM9408, GM9410, GM9412.
RECALLING FIRM/MANUFACTURER
Apotex Corp, Lincolnshire, IL, by letter dated January 19, 2005. Firm initiated recall is ongoing.
REASON
Impurities/Degradation: Degradation level exceeds specification requirement of less than 0.2% impurities.
VOLUME OF PRODUCT IN COMMERCE
121,071 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5mg/vial, 30 Sterile 2.5mL Unit-Dose Vials, For oral inhalation only, Rx only, Sterile, NDC 0487-9801-01. Recall # D-121-5.
CODE
Lot Number P4174A.
RECALLING FIRM/MANUFACTURER
Nephron Pharmaceuticals, Corp, Orlando, FL, by telephone, fax and letter on January 17-20, 2005. Firm initiated recall is ongoing.
REASON
Mislabeling: a single vial of Albuterol Sulfate Inhalation Solution found in Ipratropium Bromide Inhalation Solution, 0.02% pouches.
VOLUME OF PRODUCT IN COMMERCE
9,640 carton of 30 vials each (289,200 vials).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ethex Corporation Anemagen OB Prenatal Multivitamin and Mineral Soft Gelatin Capsules, 1 mg folic acid and 1.6 mg Vitamin B1, 100 capsules per bottle, Rx only. Recall # D-124-5.
CODE
Lot #62800, Exp. 05-2006.
RECALLING FIRM/MANUFACTURER
Ethex Corporation, Bridgeton, MO, by telephone and letter on January 31, 2005. Firm initiated recall is ongoing.
REASON
Superpotent: The batch was formulated above the USP limit for folic acid and thiamine mononitrate.
VOLUME OF PRODUCT IN COMMERCE
1,462/100-capsule bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Prascion Cleanser, (sodium sulfacetamide10% and sulfur 5%), Cleanser, Rx only, 6 oz (170.3g), Recall # D-114-5.
CODE
Lot #GB430.
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Inc., Gainesville, GA, by letter on December 30, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: sulfur (12 month stability).
VOLUME OF PRODUCT IN COMMERCE
3,609 bottles.
DISTRIBUTION
OH.

_______________________________
PRODUCT
K-Tan 4 Suspension, Each 5mL (one teaspoonful) contains: Phenylephrine Tannate 5mg, Pyrilamine Tannate 30mg, 4 fl oz (ll8mL) bottles, Rx only. NDC 66993-521-55. Recall # D-115-5.
CODE
Lot #GB643.
RECALLING FIRM/MANUFACTURER
Kiel Laboratories, Inc., Gainesville, GA, by fax and letter on October 8, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: phenylephrine tannate (24 month stability).
VOLUME OF PRODUCT IN COMMERCE
6,493 bottles.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Double Tussin DM Cough/Cold Syrup, (Dextromethorphan HBr 20 mg and Guaifenesin 300 mg), OTC, 4 oz. amber PET bottles with a white child resistant screw cap and tamper evident neck band. Recall # D-119-5.
CODE
Lot K0429, Exp. 10/06.
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton, NJ, by telephone on December 15, 2004, and by letter on December 16, 2004. Firm initiated recall is ongoing.
REASON
Presence of Precipitate.
VOLUME OF PRODUCT IN COMMERCE
7,740 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Premarin (conjugated estrogens) tablets,
USP, 0.9 mg, 100 tablet bottles, Rx,
NDC 0046-0864-81. Recall # D-122-5;
b) Prempro (conjugated estrogens/medroxyprogesterone
acetate) tablets, 0.45 mg/1.5 mg, shipped in
cartons containing 3 EZ DIAL Dispensers of 28
tablets each, Rx. NDC 0046-0937-09.
Recall # D-123-5.
CODE
a) A49687, Exp. 01/2006;
b) A49710, Exp. 06/2005, A80422, Exp. 06/2005,
and A80424, Exp. 06/2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters dated January 18, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
88,224 bottles Premarin; 74,521 cartons Prempro.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets. Recall # B-0381-5.
CODE
Unit J08361.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on December 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0450-5.
CODE
Unit numbers: 02OWIF8936, 02OWIF9969, 02OWIG0416.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Oshkosh, WI, by facsimile on January 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received MMR vaccine prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0473-5.
CODE
Unit number 6207723.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on April 15, 2004, and by letter on September 7, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0476-5;
b) Platelets, Leukocytes Reduced. Recall # B-0477-5.
CODE
a) and b) Unit numbers FG97141, LE89604.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on October 21, 2004.Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MI, RI, and NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0479-5.
CODE
Unit number: 0662304.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter, dated March 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin test performed during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0482-5.
CODE
Unit number: 261185685.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected using a hematocrit centrifuge that did not have quality control performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0549-5.
CODE
Unit 18V62680.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI, by telephone on November 15, 2004 and by letter dated November 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0550-5.
CODE
Unit 18GM14239.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI, by telephone on November 5, 2004 and by letter dated November 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced.
Recall # B-0551-5;
b) Cryoprecipitated AHF. Recall # B-0552-5;
c) Fresh Frozen Plasma. Recall # B-0553-5;
d) Plasma, Cryoprecipitate Reduced.
Recall # B-0554-5.
CODE
a) Unit 11GR41559;
b) Units 11FF84655, 11GL56432, 11GT44260,
11FW01586, 11FY19538, 11GW37928, 11GY28128,
11GV49410, 11FZ51078, 11GF35711, 11GW40541,
11FM82085;
c) Units 11GQ48977, 11GG22094, 11GT44209;
d) Units 11FF84655, 11LJ80341, 11FW01586,
11FY19538, 11GY28128, 11GV49410, 11FZ51078,
11KE39913, 11GV50515, 11GF35711, 11GW40541,
11FM82085.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on April 3, 2003 and by letter dated April 15, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
AL, AK. IL, GA, MO, OK, TN, and PR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0556-5.
CODE
Unit 33GR63495.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Connecticut Region, Farmington, CT, by telephone on October 21, 2004 and by letter dated October 22, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Source Plasma. Recall # B-0574-5.
CODE
Unit numbers: 51188702, 51180645, 39865724, 39845245, 39841193, 39822437, 39818829, 39810144, 39805799, 39797636, 39790842, 39782007, 39774132, 39771247, 39762955, and 39758354.
RECALLING FIRM/MANUFACTURER
ZLB Bioplastic, Inc, Medford, OR, by facsimile on December 6, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0575-5;
b) Recovered Plasma. Recall # B-0576-5.
CODE
a) and b) Unit number LK98270.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letters or facsimile, dated October 27, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a reported history of Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and Switzerland.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0588-5;
b) Platelets Pheresis, Leukocytes Reduced
Irradiated. Recall # B-0589-5.
CODE
a) Unit numbers 2013896, 2011743, 2010157,
and 2007667;
b) Unit numbers 2005997 and 2001553.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on August 11, 2004. Firm initiated recall is complete
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0590-5.
b) Platelets. Recall # B-0591-5.
CODE
a) and b) Unit number 2043842.
RECALLING FIRM/MANUFACTURER
Medic, Inc. Knoxville, TN, by letter on August 11, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0592-5.
CODE
Unit numbers 2015686 and 2023382.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on July 28, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0593-5.
CODE
Unit number 2515035.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on June 25, 2004. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0594-5.
CODE
Unit number 2029927.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on May 18, 2004. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0595-5.
CODE
Unit number 18GC25187.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by telephone and by letter dated December 10, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the hematocrit result was not documented on the blood donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0597-5.
CODE
Unit number J74486.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on November 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-0598-5;
b) Recovered Plasma. Recall # B-0599-5.
CODE
a) Unit R11475;
b) Unit S77924.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile and electronic mail on November 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0600-5.
CODE
Unit L59363.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on December 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0615-5;
b) Fresh Frozen Plasma. Recall # B-0616-5;
c) Cryoprecipitated AHF, Recall # B-0617-5.
CODE
a) Units FH33677 and KS29554;
b) Unit KS29554;
c) Unit FH33677.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by letter dated September 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD and VA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0620-5;
b) Platelets. Recall # B-0621-5;
c) Fresh Frozen Plasma. Recall # B-0622-5;
d) Recovered Plasma. Recall # B-0623-5.
CODE
a) Units KT32875, KT26949, KT14157, and KT19784;
b) Units KT19784 and KT14157;
c) Units KT32875, KT19784, and KT14157;
d) Unit KT26949.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by facsimile or letter dated September 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
VA, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0628-5.
CODE
Unit FW23828.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by letter dated December 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0380-5.
CODE
Unit 231453457.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by telephone on December 17, 2003. and by letter dated January 23, 2004. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested and labeled as negative for the Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.

_______________________________
PRODUCT
Platelets, Irradiated. Recall # B-0474-5
CODE
Unit number 0799631.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on November 22, 2002.
Manufacturer: Blood Centers of the Pacific, North Bay Center, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood product that was removed from controlled storage for more than allowed was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0475-5.
CODE
Unit number 04KT65714.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on September 14, 2004, and by letter on September 15, 2004.
REASON
Blood product, collected from an ineligible donor due to a history of a chronic ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0526-5.
CODE
Unit 5403969.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on February 23, 2004, and by letter dated March 2, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated. Recall # B-0587-5.
CODE
Unit number 2048005 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on September 24, 2004, and by letter on September 29, 2004. Firm initiated recall is complete.
REASON
Blood products, that were found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0596-5.
CODE
Unit 18GC25141.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by telephone on December 6, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not have the collection time documented on the blood donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
BD ProbeTecŒ ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTecŒ ET Urine Processing Pouches, 25 pouches/bag. Recall # Z-0455-05.
CODE
Lot/Exp 4103719 October 31, 2005
4118463 October 31, 2005
4119670 November 30, 2005
4124224 November 30, 2005
4133122 November 30, 2005
4105126 October 31, 2005
4118129 November 30, 2005
4104256 October 31, 2005
4091913 October 31, 2005
4104254 October 31, 2005
4090438 October 31, 2005
4090259 October 31, 2005
4084784 October 31, 2005
4014879 July 31, 2005
4016963 July 31, 2005
4023837 July 31, 2005
4023840 August 31, 2005
4041551 August 31, 2005
4083445 October 31, 2005
4133902 November 30, 2005.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by telephone on January 10, 2005. Firm initiated recall is ongoing.
REASON
An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
VOLUME OF PRODUCT IN COMMERCE
2,175 kits.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________

Note: Information on the following recall was corrected on March 24, 2005, to reflect an additional model number and to clarify the product codes involved.

PRODUCT
a) Powerheart AED G3 Automated External Defibrillator
Model 9300E. Recall # Z-0398-05;
b) Powerheart AED G3 Automated External Defibrillator
Model 9300A (Automatic). Recall # Z-0399-05.
c) Powerheart AED G3 Automated External Defibrillator
Model 9300P (Automatic). Recall # Z-0400-05.
CODE
a) Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.
b) Model no. 9300A serial numbers: 361240 thru 361317, 362360 thru 362386, 362394, 362715 thru 362914, 364195 thru 364274, 364555 thru 364594, 364915 thru 365294.
c) Model no. 9300P serial numbers: 900290 thru 900870.
RECALLING FIRM/MANUFACTURER
Cardiac Science, Inc., Minnetonka, MN, by telephone on November 12, 2004. Firm initiated recall is ongoing.
REASON
AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.
VOLUME OF PRODUCT IN COMMERCE
2,823 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) SSCOR Suction Device Model 2310BV.
Recall # Z-0411-05;
b) SSCOR Suction Device Model 2310V.
Recall # Z-0412-05;
c) SSCOR Suction Device Model 2310BV-230.
Recall # Z-0413-05;
d) SSCOR Suction Device Model 2314.
Recall # Z-0414-05;
e) SSCOR Suction Device Model 2314B.
Recall # Z-0415-05;
f) SSCOR Suction Device Model 2315.
Recall # Z-0416-05.
CODE
a) Serial Numbers: C00575 - C00624 (found on a silver
label on the back of each device);
b) Serial Number: D00150 - D00159;
c) Serial Number: G00192 - G00242;
d) Serial Number: M00402 - M00809;
e) Serial Number: N00215 - N00407;
f) Serial Number: L00396 - L00425.
RECALLING FIRM/MANUFACTURER
S S C O R Inc., Sun Valley, CA, by letter, on January 6, 2005. Firm initiated recall is ongoing.
REASON
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in question is caused by regulators that result in inadequate suction.
VOLUME OF PRODUCT IN COMMERCE
703.
DISTRIBUTION
Nationwide, France, New Zealand, Singapore, and United Kingdom.

_______________________________
PRODUCT
Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Recall # Z-0442-05.
CODE
M36262.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone and e-mail on November 11, 2004, and by letter on November 16, 2004. Firm initiated recall is ongoing.
REASON
The catheter became disconnected from the port while implanted in the patient.
VOLUME OF PRODUCT IN COMMERCE
75 trays.
DISTRIBUTION
Nationwide, Canada and Taiwan.

_______________________________
PRODUCT
Internal Battery for Puritan Bennett 700 Series Ventilator. Recall # Z-0444-05.
CODE
All produced from 3/1/02 to 5/12/04.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letters on December 16, 2004. Firm initiated recall is ongoing.
REASON
Wires on battery may loosen causing disconnection.
VOLUME OF PRODUCT IN COMMERCE
6,642 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Puritan Bennett Ventilator System. Model 740 and 760 series. Recall # Z-0445-05.
CODE
All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letter on December 17, 2004. Firm initiated recall is ongoing.
REASON
Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
VOLUME OF PRODUCT IN COMMERCE
13,010 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-123. Recall
# Z-0446-05;
b) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-125. Recall
# Z-0447-05;
c) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-127. Recall
# Z-0448-05;
d) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-140. Recall
# Z-0449-05;
e) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-142. Recall
# Z-0450-05;
f) Atlantis Element Express Kit; a sterile kit for cervical
spine surgery which includes hex-head screwdriver, bone
plate and 4 bone screws; catalog number 786-145. Recall
# Z-0451-05.
CODE
a) Lots 796010 and 634540;
b) Lots 634550, 796050 and 796040;
c) Lots 634560 and 802080;
d) Lots 634570 and 802070;
e) Lots 634580, 796070, 857390, 796030,
802090 and 878300;
f) Lots 634590, 671730, 789870, 789860,
796020, 789880 and 744910.
RECALLING FIRM/MANUFACTURER
Warsaw Orthopedic, Inc., Warsaw, IN, by letters dated December 27, 2004 and January 12, 2005. Firm initiated recall is ongoing.
REASON
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
VOLUME OF PRODUCT IN COMMERCE
900 units.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
a) OTC Pregnancy Test labeled "CHOICE Pregnancy Test Kit"
(PA-410A), midstream, no cups or droppers. Label reads:
"One Step, Easy to Use, Positive result as early as 1
minute, Over 99% accurate." Each box contains one home
test kit. Recall # Z-0452-05;
b) OTC Pregnancy Test Kit labeled "CHOICE Pregnancy Test
Kit" (PA-320), cassette type with cup and dropper.
Label states: "Easy to Use, Easy Reading, Positive
result as early as 1 minute, Over 99% accurate." Each
box contains one home test kit. Recall # Z-0453-05.
CODE
a) U060804, 30NOV06, UPC code: 010960 455000;
b) U040904, Exp. 30SEP06, UPC code: 310960 451003.
RECALLING FIRM/MANUFACTURER
International Chemical, Inc., Amherst, NY, by telephone in October 2004, and on December 27, 2004, and by letter on January 10, 2005. Firm initiated recall is ongoing.
REASON
Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
VOLUME OF PRODUCT IN COMMERCE
258 kits.
DISTRIBUTION
FL, and the Caribbean.

_______________________________
PRODUCT
Run Way 6F Cardiovascular Guide Catheter. Recall # Z-0454-05.
CODE
All models and lot numbers of the Boston Scientific Run Way 6F Guide Catheter.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by telephone on October 29, 2004 and November 2, 2004, and by letter on November 1, 2004. Firm initiated recall is ongoing.
REASON
The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon.
VOLUME OF PRODUCT IN COMMERCE
76,984 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Endopath EZ45 Endoscopic Linear Cutter (EZ45B).
Recall # Z-0457-05;
b) Endopath EZ45 No Knife Linear Stapler (NK45B).
Recall #Z-0458-05;
c) Endopath EZ45 Endoscopic Linear Cutter (EZ45G).
Recall #Z-0459-05;
d) Endopath EZ45 Endoscopic Linear Cutter (ET45B).
Recall #Z-0460-05;
e) Endopath EZ45 Endoscopic Linear Cutter (ET45G).
Recall #Z-0461-05;
f) Endopath EZ45 No Knife Linear Stapler (NK45G).
Recall #Z-0462-05.
CODE
a) EZ45B: lots T4XE79, T4XF7F, V40043, V40378,
V40379, V4080M, V4083P, V40C1U, V40H0Y, V40K5V,
V40W6T, V40X9X, V41831, V4197Y, V41A4M, V41C3Z,
V41C98, V41E71, V41F9Y, V41U9F, V41Y80, V42105,
V42220, V4231R, V4262Z, V4270F, V42C7P, V42G1X,
V42K0X, V42MOT, V42P6P, V42V2R, V42Y1J, V42Z8Z,
V43231, V43521, V4ZE36, V4ZE39, V4ZJ35, V4ZK34,
V4ZV7W, V4ZX2N.
b) NK45B: lots T4X84Z, V4ZM09;
c) EZ45G: lots T4XE2M, T4XE5A, T4XN8A, V4011N,
V4011N, V4041X, V4092A, V40C1V, V40D3K, V40G4K,
V40L3L, V40N9M, V40V5M, V40W1G, V40Y7X, V41031,
V4179G, V4188D, V4197Z, V41A60, V41C25, V41C71,
V41E2X, V41E5R, V41F9T, V41L7L, V41M2K, V41R2T,
V41U9J, V41Y64, V41Z5L, V42221, V4231M, V4262Y,
V4271Y, V42744, V4282L, V42C5L, V42G1Y, V42H1C,
V42H9A, V42K6L, V42M08, V42M6Y, V42R1A, V42T7C,
V42X1R, V4303Y, V4399, V4348J, V4369E, V4ZC23,
V4ZE3U, V4ZE3Z, V4ZG8G, V4ZH7M, V4ZP6K, V4ZU1M,
V4ZX9Z;
d) ET45B: lots V40491, V402JG, V40L7G, V40Y0V,
V40Z4T, V4115D, V41C2J, V41H9Z, V4238R, V42503,
V42D7L, V42G6T, V42H1R, V42K6M, V42P09, V42U6G,
V42Z26, V42Z27, V4Z72F, V4ZK9P, V4ZR8Y;
e) ET45G: lots T4X78R, T4XEO2, T4YH24, V4Z686,
V4Z687, V40493, V4083R, V40E8C, V40J36, V40L12,
V40X9T, V41143, V41832, V41A4H, V41U9L, V42505,
V42C8X, V42G6R, V42H22, V42K6N, V42L0H, V42M83,
V42P08, V42V6G, V42X1P, V42X6J, V4307T, V4ZL7F,
V4ZY12, V40Z2Y;
f) NK45G: Lots V40Z1C, V41M2N, V42H3V, V4Z42W,
V4ZU1N.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letters dated November 21, 2004. Firm initiated recall is ongoing.
REASON
The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
VOLUME OF PRODUCT IN COMMERCE
35,505 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Custom Order Value Pack General Anesthesia Kit, Catalog Number: VP1279, Labeled in part: Contents: 1-Adult Disposable Anesthesia Breathing Circuit **1-Breathing Bag Non-Latex**. Recall # Z-0463-05.
CODE
Lot Numbers: 205614, 223919, 504882.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by visit on April 1, 2004. Firm initiated recall is complete.
REASON
Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.
VOLUME OF PRODUCT IN COMMERCE
357 cases.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
8C390 (Reorder No. 21-0325-01) 121 inch length/307
cm, 28ml priming volume, 20 drops/ml, 0 injection
sites. Recall # Z-0464-05;
b) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
8C220 (Reorder No. 21-0323-01) 107 inch length/272
cm, 26ml priming volume, 20 drops/ml, 1 standard
injection site. Recall # Z-0465-05;
c) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. 3 Model Numbers
are used for this same Burette Administration Set
described as 110 inch length/279 cm, 16.5ml priming
volume, 20 drops/ml, 3 standard injection sites.
Model Number I8C1230J (Reorder No. 21-0301-25) for
product distributed to Japan. Model Number I8C1230
(Reorder No. (21-0318-25) for product distributed
Internationally. Model Number 8C1230 (Reorder No.
21-0305-01) for product distributed within the United
States. Recall # Z-0466-05;
d) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. 2 Model Numbers
are used for this same Specialty Administration
Set described as 105 inch length/267 cm, 25ml priming
volume, 20 drops/ml, 0 injection sites, PVC Cassette,
non-PVC lined tubing, non-PVC drip chamber. Model
Number I8C290 (Reorder No. 21-0317-25) for product
distributed Internationally. Model Number 8C290
(Reorder No. 21-0304-01) for product distributed
within the United States. Recall # Z-0467-05;
e) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. 2 Model Numbers
are used for this same Burette Administration Set
described as 110 inch length/279 cm, 16.5ml
priming volume, 60 drops/ml, 3 standard injection
sites. Model Number I8C1630 (Reorder No. 21-0319-25)
for product distributed Internationally. Model
Number 8C1630 (Reorder No. 21-0306-01) for product
distributed within the United States.
Recall # Z-0468-05;
f) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
AK2304 (Reorder No. 21-0308-01) 118 inch length/300
cm, 19ml priming volume, 60 drops/ml, 3 standard
injection sites and 0.22 micron air-eliminating
filter. Recall # Z-0469-05;
g) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC2102 (Reorder No. 21-0309-01) 112 inch length/
285 cm, 50ml priming volume, 12 drops/ml (at
filter), 1 SureSite Prepierced injection site,
150 micron blood filter, 2 non-vented spikes.
Recall # Z-0470-05;
h) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CJ4303 (Reorder No. 21-0313-01) 110 inch length/
279 cm, 16.5ml priming volume, 20 drops/ml, 3
SureSite Prepierced injection sites.
Recall # Z-0471-05;
i) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. 2 Model Numbers
are used for this same Primary Administration Set described as 105 inch length/267 cm, 25ml priming
volume, 20 drops/ml, 2 standard injection sites.
Model Number I8C230 (Reorder No. (21-0345-25)
for product distributed Internationally. Model
Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States.
Recall # Z-0472-05;
j) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. 2 Model Numbers
are used for this same Primary Checkvalve Set for
secondary (piggyback) Administration described as
105 inch length/267 cm, 25ml priming volume, 20
drops/ml, 2 standard injection sites. Model Number
I8C4220 (Reorder No. 21-0349-25) for product
distributed Internationally. Model Number 8C4220
(Reorder No. 21-0328-01) for product distributed
within the United States. Recall # Z-0473-05;
k) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
AC2029 (Reorder No. 21-0330-01) Speciality
Administration Low Adsorption Filter Set has
105 inch length/267 cm, 27.5ml priming volume,
20 drops/ml, 0 injection sites, 0.22 micron air-
eliminating filter, PVC Cassette, non-PVC lined
tubing, non-PVC drip chamber. Recall # Z-0474-05;
l) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC1201 (Reorder No. 21-0333-01) Primary Checkvalve
for Secondary (piggyback) Administration Set
described as 105 inch length/267 cm, 25ml
priming volume, 20 drops/ml and 2 SureSite
Prepierced Injection sites. Recall # Z-0475-05;
m) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC1301 (Reorder No. 21-0334-01) Primary Checkvalve
for Secondary (piggyback) Administration Set
described as 115 inch length/292 cm, 27ml
priming volume, 20 drops/ml and 3 SureSite
Prepierced Injection sites. Recall # Z-0476-05;
n) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC2204 (Reorder No. 21-0336-01) Speciality
Administration Filter Set has 107 inch length/272
cm, 28ml priming volume, 20 drops/ml, 2 SureSite
Prepierced Injection sites and 0.22 micron air-
eliminating filter. Recall # Z-0477-05;
o) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC3217 (Reorder No. 21-0338-01) Speciality
Administration Checkvalve Filter Set has 107 inch
length/272 cm, 27.5ml priming volume, 20 drops/ml,
2 SureSite Prepierced Injection sites and 0.22
micron air-eliminating filter. Recall # Z-0478-05;
p) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CC4203 (Reorder No. 21-0339-01) 105 inch
length/267 cm, 25.5ml priming volume, 20 drops/ml,
2 SureSite Prepierced Injection Sites.
Recall # Z-0479-05;
q) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
CF4203 (Reorder No. 21-0340-01) 105 inch
length/267 cm, 25ml priming volume, 60 drops/ml,
2 SureSite Prepierced Injection Sites.
Recall # Z-0480-05;
r) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
LC4203 (Reorder No. 21-0341-01) 105 inch
length/267 cm, 25ml priming volume, 20 drops/ml,
2 needleless Injection Sites. Recall # Z-0481-05;
s) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
NJ4303 (Reorder No. 21-0426-01) described as 110
inch length/279 cm, 16.5ml priming volume, 20
drops/ml, 3 Luer-Activated Valve injection Sites
Burette set. Recall # Z-0482-05;
t) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
NK4303 (Reorder No. 21-0427-01) described as 110
inch length/279 cm, 16.5ml priming volume, 60
drops/ml, 3 Luer-Activated Valve injection Sites
Burette set. Recall # Z-0483-05;
u) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
NC1301 (Reorder No. 21-0428-01) Primary Checkvalve
for Secondary (piggyback) Administration set
described as 115 inch length/292 cm, 27ml priming
volume, 20 drops/ml, 3 Luer-Activated Valve
injection Sites. Recall # Z-0484-05;
v) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
NJ2304 (Reorder No. 21-0433-01) Burette
Administration Set described as 110 inch length
/279 cm, 20ml priming volume, 20 drops/ml, 3
Luer-Activated Valve Injection Sites.
Recall # Z-0485-05;
w) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
8C4209 (Reorder No. 21-0327-01) Primary one-way
Checkvalve below pump Administration set
described as 115 inch length/292 cm, 27.5ml
priming volume, 20 drops/ml and 3 injection Sites.
Recall # Z-0486-05;
x) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
I8C820 (Reorder No. 21-0346-25) Primary
Administration set described as 105 inch
length/267 cm, 25ml priming volume, 20 drops/ml
and 1 injection Site. Recall # Z-0487-05;
y) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
I8C825 (Reorder No. 21-0347-25) Specialty
Administration set described as 109 inch
length/277 cm, 26ml priming volume, 20 drops/ml
and 1 injection Site. Recall # Z-0488-05;
z) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
I8C4240J (Reorder No. 21-0352-25) Specialty
Administration set described as 107 inch
length/272 cm, 27.5ml priming volume, 20 drops/ml
and 2 injection Sites and 0.22 micron filter.
Recall # Z-0489-05;
aa) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
RC4106 (Reorder No. 21-0402-25) Primary
Administration set described as 105 inch
length/267 cm, 25ml priming volume, 20
drops/ml and 1 Needleless Injection Site.
Recall # Z-0490-05;
bb) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
RC42124 (Reorder No. 21-0441-25) Specialty
Administration set described as 109 inch
length/277 cm, 26ml priming volume, 20 drops/ml
and 1 Needleless injection Site, 15 micron filter.
Recall # Z-0491-05;
cc) Deltec branded Administration Sets for use with
Deltec 3000 and 3100; Graseby 500, 505 and AVI
Volumetric Infusion Pump Systems. Model Number
RC1201 (Reorder No. 21-0442-25) Primary Checkvalve
Administration set described as 105 inch
length/267 cm, 25ml priming volume, 20
drops/ml and 2 Needleless Injection Sites.
Recall # Z-0492-05;
CODE
a) Lot No: FEB04T29;
b) Lot No. FEB04T08, MAR04T26 and APR04T07;
c) Lot No. FEB04T28, MAR04T23 & MAR04T34.
Lot No. FEB04T22, MAR04T31, APR04T06 & APR04T10.
Lot No. FEB04T27 & APR04T13;
d) Lot no. FEB04T17 & APR04T09.
Lot no. FEB04T06, MAR04T07, APR04T23;
e) Lot No. APR04T02, Lot No.: MAR04T04;
f) Lot No. FEB04T32;
g) Lot No. MAR04T08;
h) Lot No. FEB04T16, MAR04T20 & APR04T18;
i) Lot No. MAR04T03 & APR04T04,
Lot No. FEB04T01, FEB04T18, MAR04T02,
APR04T03 & APR04T16;
j) Lot No. FEB04T24 & MAR04T14,
Lot No. MAR04T21 & APR04T08;
k) Lot No. FEB04T2;
l) Lot No. FEB04T10, MAR04T09 & APR04T29;
m) Lot No. FEB04T31, MAR04T22 & APR04T19;
n) Lot No. APR04T27;
o) Lot No. MAR04T13;
p) Lot No. FEB04T11, FEB04T30,MAR04T05 and
MAR04T24;
q) Lot No. APR04T28;
r) Lot No. FEB04T09, FEB04T34, MAR04T16 & APR04T05;
s) Lot No. MAR04T12;
t) Lot No. MAR04T15;
u) Lot No. APR04T24;
v) Lot No. FEB04T07;
w) Lot No. MAR04T17;
x) Lot No. FEB04T02, FEB04T03, FEB04T04, FEB04T12,
FEB04T19, FEB04T20, FEB04T21, FEB04T35, FEB04T36,
FEB0437, MAR04T01, MAR04T10, MAR04T11, MAR04T18,
MAR04T25, MAR04T27, MAR04T28, MAR04T32, MAR04T33,
MAR04T35, MAR04T36, APR04T01, APR04T11, APR04T12,
APR04T15, APR04T21, APR04T25 & APR04T26;
y) Lot No. FEB04T13, FEB04T33 & MAR04T29;
z) Lot No. FEB04T25;
aa) Lot No. FEB04T15, APR04T14 & APR04T22;
bb) Lot No. FEB04T05, MAR04T30 & APR04T20;
cc) Lot No. FEB04T26.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by facsimile letter on December 3, 2004. Firm initiated recall is ongoing.
REASON
Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leak past and may cause an inaccurate infusion rate.
VOLUME OF PRODUCT IN COMMERCE
1,264,610 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Versapoint, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). The product subject of this recall is the connector cable which goes between the electrosurgical generator and the electrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization. Product code 00480. Recall # Z-0493-05.
CODE
Lot #'s: 0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029,
0409080, 0410021, 0410103, 0411040.
RECALLING FIRM/MANUFACTURER
Ethicon, Inc., Somerville, NJ, by letter on December 14, 2004. Firm initiated recall is ongoing.
REASON
Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.
VOLUME OF PRODUCT IN COMMERCE
768 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Lifepak 12 defibrillator/monitors biphasic. Recall # Z-0495-05.
CODE
VLP12-02 Part Numbers all with a Biphasic label on the front of the device.
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on January 15, 2005, and January 17, 2005. Firm initiated recall is ongoing.
REASON
The monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
VOLUME OF PRODUCT IN COMMERCE
35,709.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Proven Porous CR Femur, Implantable orthopedic device. Recall # Z-0496-05.
CODE
Catalog number SC2113-2 Lot number 3763-012501,
Catalog number SC2113-3 Lot number 3764-012501,
Catalog number SC2113-4 Lot number 3765-012501,
Catalog number SC2113-1 Lot number 3762-012501,
Catalog number SC2113-6 Lot number 3767-012501,
Catalog number SC2113-5 Lot number 3766-012501,
Catalog number SC2114-4 Lot number 3771-012501,
Catalog number SC2114-3 Lot number 3770-012501,
Catalog number SC2114-1 Lot number 3768-012501,
Catalog number SC2114-2 Lot number 3769-012501,
Catalog number SC2114-6 Lot number 3773-012501,
Catalog number SC2114-5 Lot number 3772-012501.
RECALLING FIRM/MANUFACTURER
Stelkast Co., McMurray, PA, by telephone on September 24, 2004. Firm initiated recall is complete.
REASON
Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch.
VOLUME OF PRODUCT IN COMMERCE
105 units.
DISTRIBUTION
AZ, CA, MO, NC, PA, and WV.

_______________________________
PRODUCT
a) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=22mm, B=112mm, C=82mm, D=11mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-22-82.
Recall # Z-0498-05;
b) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=26mm, B=112mm, C=82mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-24-82.
Recall # Z-0499-05;
c) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=24mm, B=112mm, C=82mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-26-82.
Recall # Z-0500-05;
d) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=24mm, B=112mm, C=82mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-28-82.
Recall # Z-0501-05;
e) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=30mm, B=112mm, C=82mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-30-82.
Recall # Z-0502-05;
f) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=32mm, B=112mm, C=82mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-32-82.
Recall # Z-0503-05;
g) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=22mm, B=126mm, C=96mm, D=11mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-22-96.
Recall # Z-0504-05;
h) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=24mm, B=126mm, C=96mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-24-96.
Recall # Z-0505-05;
i) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=26mm, B=126mm, C=96mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-26-96.
Recall # Z-0506-05;
j) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=28mm, B=126mm, C=96mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-28-96.
Recall # Z-0507-05;
k) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=30mm, B=126mm, C=96mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-30-96.
Recall # Z-0508-05;
l) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=32mm, B=126mm, C=96mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-32-96.
Recall # Z-0509-05;
m) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=22mm, B=141mm, C=111mm, D=11mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-22-111.
Recall # Z-0510-05;
n) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=24mm, B=141mm, C=111mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-24-111.
Recall # Z-0511-05;
o) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=26mm, B=141mm, C=111mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-26-111.
Recall # Z-0512-05;
p) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=28mm, B=141mm, C=111mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-28-111.
Recall # Z-0513-05;
q) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=30mm, B=141mm, C=111mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-30-111.
Recall # Z-0514-05;
r) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=32mm, B=141mm, C=111mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-32-111.
Recall # Z-0515-05;
s) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=22mm, B=155mm, C=125mm, D=11mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-22-125.
Recall # Z-0516-05;
t) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=24mm, B=155mm, C=125mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-24-125.
Recall # Z-0517-05;
u) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=26mm, B=155mm, C=125mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-26-125.
Recall # Z-0518-05;
v) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=28mm, B=155mm, C=125mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-28-125.
Recall # Z-0519-05;
w) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=30mm, B=155mm, C=125mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-30-125.
Recall # Z-0520-05;
x) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=32mm, B=155mm, C=125mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-32-125.
Recall # Z-0521-05;
y) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=26mm, B=170mm, C=140mm, D=12mm, E=18.0f,
F=.035", G=40cm); Reorder number TFBB-26-140.
Recall # Z-0522-05;
z) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=28mm, B=170mm, C=140mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-28-140.
Recall # Z-0523-05;
aa) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=30mm, B=170mm, C=140mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-30-140.
Recall # Z-0524-05;
bb) Cook brand Zenith Flex AAA Endovascular graft
with the H&L-B One Shot Introduction System
(A=32mm, B=170mm, C=140mm, D=12mm, E=20.0f,
F=.035", G=40cm); Reorder number TFBB-32-140.
Recall # Z-0525-05;
CODE
All units distributed on or before 12/17/04.
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letter dated December 20, 2004. Firm initiated recall is ongoing.
REASON
The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
VOLUME OF PRODUCT IN COMMERCE
453 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Dental Explorer #2 D/E, Mfr. Part Code/Product
Code 101-0913, distributed under the Henry
Schein label. Product is labeled in part, HENRY
SCHEINÆ 101-0913 Explorer #2 D/E. +H658101091306.
Made in China. For professional use only.
Instruments must be cleaned and sterilized
prior to use. This product is a dental explorer
made of stainless steel packaged individually
within a sleeve and containing a cardboard
insert (labeling). Recall # Z-0526-05;
b) Dental Explorer #23 S/E, Mfr. Part Code/Product
Code 100-3620, distributed under the Henry
Schein label. The product is labeled in part,
HENRY SCHEINÆ 100-3620 Explorer-Single End #23 SE.
+H658100362003. Made in China. For professional
use only. Instruments must be cleaned and
sterilized prior to use. This product is a dental
explorer made of stainless steel packaged
individually within a sleeve and containing a
cardboard insert (labeling). Recall # Z-0527-05;
c) Dental Explorer D/E #5, Mfr. Part Code/Product
Code 100-8008, distributed under the Henry
Schein label. The product is labeled in part,
HENRY SCHEINÆ 100-8008 Explorer-Double End #5.
Bar Code: +H658100800808. Made in China. For
professional use only. Instruments must be
cleaned and sterilized prior to use. This
product is a dental explorer made of stainless
steel packaged individually within a sleeve
and containing a cardboard insert (labeling).
Recall # Z-0528-05.
d) Dental Explorer Single End #7, Mfr. Part
Code/Product Code 100-7409. Distributed under
the Henry Schein label. The product is labeled
in part, HENRY SCHEINÆ 100-7409 Explorer --
Single End #7 SE. Bar Code: +H65810074090C.
Made in China. For professional use only.
Instruments must be cleaned and sterilized prior
to use. This product is a dental explorer
made of stainless steel packaged individually
within a sleeve and containing a cardboard
insert (labeling). 0Recall # Z-0529-05.
CODE
a) and c) Lot Numbers: 0503, 0603, 0903, 1003, 1103;
b) and d) Lot Numbers: 0503, 0603, 0903, 1003, 1103, 1203.
RECALLING FIRM/MANUFACTURER
Hu-Friedy Manufacturing Co., Inc., Chicago, IL, by telephone on January 7, 2005 and by letter on January 10, 2005 and January 21, 2005. Firm initiated recall is ongoing.
REASON
Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.
VOLUME OF PRODUCT IN COMMERCE
42,517 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers). Recall # Z-0530-05.
CODE
NEXUS Product List Of Catalog Numbers & Lot Numbers Catalog Number Lot Number/s 1000-3000 300510 303512A 302909A 303012 302812A 302912 302109 303009 1000-3001 326408A 304009 304509 1000-3003 301210 305809A 305509 304709A 305109 324508 1000-3004 304011A 310110 303911A 1000-3005 304211A 312410 301112 304311 1000-3010 302407 300404 1000-3011 313207 1000-3013 307404 312107 312307A 1000-3015 306911A 309505 305605 305905 307111.
RECALLING FIRM/MANUFACTURER
Interpore Cross International, Inc., Irvine, CA, by letters on January 18, 2005. Firm initiated recall is complete.
REASON
Mislabeled. International Product Information Data Sheet was inadvertently released with the products distributed in the US. International sheet contained an indication for use statement which was not cleared in the USA. This indication is, "nexus, A Geo Structure is indicated for use in an open approach using bone graft materials in patients with degenerative disc disease (DDD) (C2-S1) whose condition required the use of interbody fusion. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s)."
VOLUME OF PRODUCT IN COMMERCE
63 units.
DISTRIBUTION
TN, MT, MI, CA, IN, PA, NJ, TX, KY, LA, and CO.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Weck, Endo5, Hem-o-lok’ ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure SystemsŒ. Catalog #544965. Recall # Z-0393-05.
CODE
Lot #694505 and 694506.
RECALLING FIRM/MANUFACTURER
Weck, Research Triangle Park, NC, by letter on October 31, 2001. Firm initiated recall is complete.
REASON
The flush port on some appliers was occluded with an epoxy resin during manufacturing.
VOLUME OF PRODUCT IN COMMERCE
66 appliers.
DISTRIBUTION
Nationwide, Australia, Singapore, and Venezuela.

_______________________________
PRODUCT
Charger Assembly, Model # SC-5300, of the Precision Spinal Cord Stimulation System. Recall # Z-0396-05.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corporation, Sylmar, CA, by letter on November 11, 2004. Firm initiated recall is ongoing.
REASON
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
VOLUME OF PRODUCT IN COMMERCE
237 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately. Recall # Z-0417-05.
CODE
Model number 240-099-011 - Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020.
Model number 240-099-012 - Serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. Model number 240-099-020 - Serial numbers 040212001-032, 040309001-007, 040313001-010.
Model number 240-099-021 - Serial numbers 040224001-021, 040313017.
Model number 240-099-050 - Serial numbers 031218001-005, 031218031-045.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letter on November 30, 2004. Firm initiated recall is ongoing.
REASON
A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.
VOLUME OF PRODUCT IN COMMERCE
276 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6" -- 11 French, Rx Only, Sterile. Catalogue #809600. Recall # Z-0418-05.
CODE
Lot #978933 and 978934.
RECALLING FIRM/MANUFACTURER
Weck, Research Triangle Park, NC, by letter on/about May 21, 2003. Firm initiated recall is complete.
REASON
Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
VOLUME OF PRODUCT IN COMMERCE
667 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two -- 6 oz. bottles of TruRepair Powder. Catalog 092160. Recall # Z-0419-05.
CODE
Lot number 0404-220, exp. 2007-04.
RECALLING FIRM/MANUFACTURER
Harry J. Bosworth Co., Skokie, IL, by telephone on September 23, 2004. Firm initiated recall is ongoing.
REASON
The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If the Trusoft liquid is used the repair material will not set up.
VOLUME OF PRODUCT IN COMMERCE
38 kits.
DISTRIBUTION
NY, WA, NJ, AZ, MN, WI, OR and CA.

_______________________________
PRODUCT
Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray. 12 trays per bag; catalog 0921885. UPC +D68109218850G. Recall # Z-0420-05.
CODE
Product with date stamps of 4/6/2004, 5/4/2004, 6/16/2004, 7/22/2004, 7/23/2004 and 8/16/2004.
RECALLING FIRM/MANUFACTURER
Harry J. Bosworth Co., Skokie, IL, by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.
REASON
The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
VOLUME OF PRODUCT IN COMMERCE
13,904 trays.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator -- Blue, and one 7.5 oz, tube of Base -- White, which are mixed as needed to make the registration paste. Catalog 0921815. Recall # Z-0421-05.
CODE
Lot numbers 0407-376, exp. 2007-07;
0407-373, exp. 2007-07;
0409-526, exp. 2007-09.
RECALLING FIRM/MANUFACTURER
Harry J. Bosworth Co., Skokie, IL, by telephone on September 2, 2004 and by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.
REASON
The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
VOLUME OF PRODUCT IN COMMERCE
436 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Mammotome EX Holster. Recall # Z-0440-05.
CODE
HRDE39904, HRDE40502, HRDE40102, HRDE39920 HRDE40209, HRDE40204, HRDE39916, HRDE40220, HRDE39921, HRDE40114, HRDE40225, HRDE40508, HRDE40210, HRDE40222, HRDE39919, HRDE39906, HRDE40218, HRDE40724, HRDE40109, HRDE39903 HRDE40106, HRDE40118, HRDE40203, HRDE40113, HRDE40511, HRDE40206, HRDE39908, HRDE39910, HRDE40701, HRDE40513, HRDE40713, HRDE40720, HRDE40718, HRDE40710, HRDE40704, HRDE40716, HRDE40706, HRDE40520, HRDE40722, HRDE40708 HRDE40714, HRDE40522, HRDE40719, HRDE40705, HRDE40525, HRDE40527, HRDE40721, HRDE40703, HRDE40516, HRDE40725, HRDE40709, HRDE40702, HRDE40715, HRDE40518, HRDE40506, HRDE40519, HRDE40707, HRDE40712, HRDE40711, HRDE39922 HRDE40103, HRDE39901, HRDE40126, HRDE40120, HRDE39905, HRDE40723, HRDE40101, HRDE40205, HRDE40214, HRDE40526, HRDE40618, HRDE39902, HRDE40202, HRDE40122, HRDE40217, HRDE40221, HRDE40216, HRDE40624, HRDE39924, HRDE40717 HRDE40226, HRDE40503, HRDE40213, HRDE40107, HRDE40110, HRDE40524, HRDE40121, HRDE40514, HRDE39925, HRDE39909, HRDE39912, HRDE40505, HRDE40112, HRDE40212, HRDE40510, HRDE40208, HRDE40201, HRDE39907, HRDE39926, HRDE40124 HRDE40223, HRDE39923, HRDE40219, HRDE40111, HRDE40509, HRDE40515, HRDE40517, HRDE40108, HRDE39918, HRDE40521, HRDE40123, HRDE39914, HRDE39915, HRDE40501, HRDE40211, HRDE40224, HRDE40105, HRDE40207, HRDE39911, HRDE39911,
HRDE 39913.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated December 10, 2004. Firm initiated recall is ongoing.
REASON
A capacitor of the wrong value was used. With the improper capacitor, the speed is reduced. This may lead to failure to completely close. If it does occur, the result may be a decrease in sample size, some tearing of the tissue or no specimen at all (dry tap).
VOLUME OF PRODUCT IN COMMERCE
120 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D. Recall # Z-441-05.
CODE
Lot Number 708E.
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Worth, TX, by letter on January 3, 2005. Firm initiated recall is ongoing.
REASON
Device is missing the sub-collet component within the dissecting tool package.
VOLUME OF PRODUCT IN COMMERCE
22 tools.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar; 60 sets per case. Recall # Z-0443-05.
CODE
Lots UR192765, UR192815, UR192856, UR194290, UR200097, UR200964, UR203109, UR204693, UR208017, UR208116, UR208371, UR209569, UR209791, UR213769, UR215699, UR217141, UR218172, UR218560, UR218669, UR218982, UR222679, UR224584, UR225227, UR227884, UR228353, UR229310, UR232892, UR233841, UR234443, UR234666, UR236554, UR236588, UR239087.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp., Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.
REASON
The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
VOLUME OF PRODUCT IN COMMERCE
485,197 sets.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
BacT/Alert’ (BTA) Classic instruments. Recall # Z-0456-05.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on September 17, 2004. Firm initiated recall is ongoing.
REASON
Over heating of memory board.
VOLUME OF PRODUCT IN COMMERCE
1,626 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Equator Forced Air Convective Warming System, Reference Number EQ 5000. Recall # Z-0497-05.
CODE
Serial No. 2004126, 10040116, 20020088, 20020125, 20030104, 20030105, 20030133, 20030141, 20030146, 20030194, 20030199, 20030254, 20030287, 20030312, 20030394, 20030401, 20030408, 20030428, 20030460, 20030512, 20030522, 20030535, 20030627, 20030665, 20030759, 20030791, 20030818, 20030960, 20031030, 20031034, 20031039, 20031049, 20031056, 20031105, 20031151, 20031164, 20031172, 20031271, 20031336, 20031414, 20031417, 20031418, 20031423, 20031444, 20031488, 20031550, 20031622, 20031632, 20031661, 20031669, 20031681, 20040007, 20040010, 20040014, 20040021, 20040104, 20040106, 20040115, 20040124, 20040127, 20040153, 20040162, 20040164, 20040166, 20040202, 20040203, 20040208, 20040227, 20040290, 20040377, 20040378, 20040379, 20040380, 20040381, 20040382, 20040383, 20040385, 20040386, 20040387, 20040388, 20040389, 20040391, 20040392, 20040393, 20040394, 20040395, 20040396, 20040397, 20040398, 20040399, 20040400, 20040401, 20040402, 20040406, 20040408, 20040409, 20040410, 20040412, 20040414, 20040415, 20040416, 20040419, 20040420, 20040422, 20040427, 20040429, 20040505, 20040715, 20040817, 20040996, 20041156, 20041157, 20041158, 20041159, 20041160, 20041161, 20041162, 20041163, 20041164, 20041165, 20041166, 20041167, 20041168, 20041169, 20041170, 20041171, 20041172, 20041173, 20041174, 20041175, 20041176, 20041177, 20041178, 20041179, 20041180, 20041181, 20041182, 20041183, 20041184, 20041185, 20041186, 20041187, 20041188, 20041189, 20041190, 20041191, 20041192, 20041193, 20041194, 20041195, 20041196, 20041197, 20041198, 20041199, 20041200, 20041201, 20041202, 20041203, 20041204, 20041205, 20041206, 20041207, 20041208, 20041209, 20041210, 20041211, 20041212, 20041213, 20041214, 20041215, 20041216, 20041217, 20041218, 20041219, 20041220, 20041221, 20041222, 20041223, 20041224, 20041225, 20041227, 20041228, 20041229, 20041230, 20041231, 20041232, 20041233, 20041234, 20041235, 20041236, 20041237, 20041238, 20041239, 20041240, 20041241, 20041242, 20041244, 20041245, 20041246, 20041247, 20041249, 20041250, 20041251, 20041253, 20041256, 20041257, 20041258, 20041259, 20041260, 20041261, 20041262, 20041263, 20041264, 20041265, 20041266, 20041267, 20041268, 20041269, 20041270, 20041271, 20041272, 20041273, 20041274, 20041275, 20041276, 20041277, 20041278, 20041279, 20041280, 20041281, 20041282, 20041283, 20041284, 20041285, 20041286, 20041287, 20041288, 20041289, 20041290, 20041291, 20041293, 20041294, 20041295, 20041296, 20041297, 20041298, 20041299, 20041300, 20041301, 20041302, 20041303, 20041304, 20041305, 20041306, 20041307, 20041308, 20041309, 20041310, 20041311, 20041312, 20041313, 20041314, 20041315, 20041316, 20041317, 20041318, 20041319, 20041320, 20041321, 20041322, 20041323, 20041324, 20041325, 20041326, 20041327, 20041364, 20041581, 29941255.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter on December 15, 2004. Firm initiated recall is ongoing.
REASON
Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt.
VOLUME OF PRODUCT IN COMMERCE
206 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Boehringer Ingelheim Atgard (dichlorvos) Swine Wormer, Packaged in 1.92 oz. (54.6 g) laminated pouches containing 0.40 oz. (11.5 g) dichlorvos (2,2-dichlorovinyl dimethyl phosphate) in a stabilized polyvinyl chloride/plasticizer resin pellet, packaged 5 packets per display carton, 6 display cartons per master display carton, NADA #043-606. Recall # V-042-5.
CODE
Lot #062AY01, Exp. 06-05, and Lot #112AY02, Exp. 11-05.
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Vetmedica, Inc, Saint Joseph, MO, by letter dated January 14, 2005. Firm initiated recall is ongoing.
REASON
Delamination of the pouches during extended storage.
VOLUME OF PRODUCT IN COMMERCE
27,150 pouches.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR FEBRUARY 16, 2005

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