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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May 4, 2005
05-18

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Roxy Brand White Sesame Seeds, 4 oz with UPC 051299 120320 and 16 oz with UPC 051299 120344 clear plastic bags with Chinese wording and Roxy logo, Red, Gold and White package. Recall # F-278-5.
CODE
Product sold after June 26, 2004.
RECALLING FIRM/MANUFACTURER
Roxy Trading, Inc., Azusa, CA, by letter on August 3, 2004. Firm initiated recall is complete.
REASON
Routine testing conducted by the State of California Department of Health Services revealed the presence of Salmonella in a sample of "Roxy Brand White Sesame Seeds".
VOLUME OF PRODUCT IN COMMERCE
2,675.
DISTRIBUTION
CA, and HI.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
Cross & Blackwell Worcestershire Sauce packaged in 5 fluid ounce bottles. Recall # F-277-5.
CODE
Lot codes: L3315, L3345, L4022, L4054, L4093, L4097, L4099, and L4330.
RECALLING FIRM/MANUFACTURER
JM Smucker Co., Orrville. OH, by telephone, fax, and letter, dated February 18, 2005. Firm initiated recall is complete.
REASON
The product contains Sudan 1, a color additive not approved for food use.
VOLUME OF PRODUCT IN COMMERCE
2436 cases, each case containing 12/5 fluid ounce bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

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PRODUCT
Clostridium Botulinum Toxin Type A. Each vial contains 5.Ong stabilized toxin; 500 IU (LD50 mouse units), labeled, For Research Purposes Only, Not For Human Use. Recall # D-204-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Toxin Research International AKA TRI, Tucson, AR, by letters on January 27, 2004. Firm initiated recall is ongoing.
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
1,831.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Oncaspar, 1 unit dose per unit package, BLA STN 103411, 750 I.U. per mL, Sterile, NDC 57665-002-02. Recall # D-205-5.
CODE
Lot number: AC0408 Exp. Date: 3/16/2006.
RECALLING FIRM
Enzon Pharmaceuticals, Inc., South Plainfield, NJ, by fax on March 21, 2005. Firm initiated recall is ongoing.
REASON
Superpotent Increase or potential of increase in enzymatic activity in vitro above specification before expiry date.
VOLUME OF PRODUCT IN COMMERCE
2,203 vials.
DISTRIBUTION
Nationwide.

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PRODUCT
Gas-X with Maalox Extra Strength Antigas plus Antiacid (Calcium Carbonate 500mg and Simethicone 125mg), 24 count blister package. NDC 0067-0130-24. Recall # D-207-5.
CODE
Lot numbers: 98207, 98208, 98209, 98236, 98237, 98246 all expiration date Sept. 30, 2006.
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health Care, Carolina, PR, by letter dated February 23, 2005. Firm initiated recall is ongoing.
REASON
Microbial test specification failure; (Staphylococcus aureus).
VOLUME OF PRODUCT IN COMMERCE
90,000 blister packs.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Prochlorperazine Suppositories, USP, 2.5mg,
12 count package, Pediatric-Size Suppositories,
Rx Only, For Rectal Use Only, NDC 53265-243-12.
Recall # D-209-5;
b) Prochlorperazine Suppositories, 5mg,
12 count package, For Older Children (Not under
40 lbs.) Rx Only, For Rectal Use Only,
NDC 53265-244-12. Recall # D-210-5.
CODE
a) Lot 308029A, 7/31/2005;
b) Lot 308030A, 7/31/2005.
RECALLING FIRM
Able Laboratories, Inc., South Plainfield, NJ, by letters on April 5, 2005. Firm initiated recall is ongoing.
REASON
Impurity failures (18 month).
VOLUME OF PRODUCT IN COMMERCE
5,681 -- 2.5mg and 23,159 -- 5mg.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Fougera Betamethasone Dipropionate Ointment USP, 0.05% (Potency expressed as betamethasone), net wt 45 grams, Rx only, NDC 0168-0056-46. Product is a topical ointment which is packed in a tube and packaged in a unit carton. Recall # D-191-5.
CODE
Lot N085, Exp. Date 12/06.
RECALLING FIRM/MANUFACTURER
Altana, Inc., Melville, NY, by letters, dated March 31, 2005, and response forms on April 4, 2005. Firm initiated recall is ongoing.
REASON
Superpotent: out-of-specification stability test result of 113.9% for the betamethasone dipropionate assay at 12-month time point.
VOLUME OF PRODUCT IN COMMERCE
42,090 units.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Trecator SC Tablets (ethionamide), 250 mg, Sugar-Coated, 100-count bottles, Rx only. NDC 0008-4130-01. Recall # D-206-5.
CODE
A86012, Exp. July 2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA, by letters dated April 7, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Dissolution failure (3 month stability).
VOLUME OF PRODUCT IN COMMERCE
166 bottles.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Glyburide Tablets, USP (micronized) 1.5mg, 100 count bottles, Rx only, NDC 0143-9918-01. Recall # D-208-5.
CODE
Lot number: 60831A, Exp. 11/06.
RECALLING FIRM
Recalling Firm: West-Ward Pharmaceutical Corp, Eatontown, NJ, by telephone and letter dated March 3, 2005.
Manufacturer: Hikma Pharmaceuticals, Amman, Jordan. Firm initiated recall is ongoing.
REASON
Misbranding: tablets debossed with incorrect code (G2 indicated for 3.Omg strength).
VOLUME OF PRODUCT IN COMMERCE
1,308 bottles of 100 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
HNA Classic 306 Patient Manager Blood Bank Software. Recall # B-0843-5.
CODE
Revision 159 and higher.
RECALLING FIRM/MANUFACTURER
Cerner Corporation, Kansas City, MO, by telephone calls beginning on 2/25/05, and completed by March 1, 2005. Firm initiated recall is ongoing.
REASON
Defects in the design of blood bank software could result in loss of patient antibody information.
VOLUME OF PRODUCT IN COMMERCE
246 software packages.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-0919-5.
CODE
Unit: 26FQ22950.
RECALLING FIRM
The American National Red Cross, Gulf Coast Region, Mobile, AL, by telephone on February 6, 2002. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0959-5;
b) Platelets. Recall # B-0960-5.
CODE
a) and b) Unit number: 32KQ73643.
RECALLING FIRM/MANUFACTURER
American Red Cross, Badger-Hawkeye Region, Madison, WI, by letter, dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI, and IL.

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PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0962-5.
CODE
Unit: 19GW46817.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter dated November 21, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

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PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0968-5.
CODE
Unit: 101858379.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 14, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

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PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0969-5.
CODE
Unit: 102953958.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated December 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

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PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0970-5.
CODE
Unit: 102920115.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated October 19, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

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PRODUCT
Blood Bank Devices. Recall # B-0973-5.
a) Neonatal Pediatric Aliquot System;
b) Neonatal/Pediatric Syringe System;
c) Blood Administration Set;
d) Plasma/Fluid Transfer Set;
e) Pooling Harness Set;
f) Blood Transfer Bag;
g) Blood Freezing Bag;
h) Stem Cell Freezing Bag;
i) Platelet Sampling Device.
CODE
a) Product Numbers: T2008, T2182, T2183, T2186, T2188,
T3000, T3001, T3002, T3003, T3007, T3605, T3607;
b) Product Numbers: 03-960-32, 03-960-33, 03-960-34,
03-960-57;
c) Product Numbers: 03-110-01, 03-110-65, 01-110-85,
03-111-02, 03-111-03, 03-118-01, 03-122-00, 03-122-10,
03-202-13;
d) Product Numbers: 03-220-00, 03220-01, 03-220-10,
03-220-30, 03-220-31, 03-220-50, 03-220-90, 03-220-91,
03-220-92, 03-220-94, 03-220-95, 03-220-99, 03-220-ACP;
e) Product Numbers: T3006, T3194, T3198, T3199, T4004,
T4006, T6010, T8004, T6006, T8005, T8006, T8010, T9006;
f) Product Numbers: T3101, T3104, T3106, T3107, T3108,
T3109, T3135, T3137, T3160, T3196, T3972, T3992, T3103,
T3106X2, T3108SL, T9700, BT1000, BT300, BT600, C600,
C605, C1000-QD, C605SWL, CBC-400;
g) Product Numbers: T3400, T3401, T8703, T8703H;
h) Product Numbers: LN025S01, LN060SO1, LN060T02,
LN075S01;
i) Product Numbers: 03-220-AC, 03-220-BC, 03-220-LKY,
03-220-TMR.
RECALLING FIRM/MANUFACTURER
Charter Medical Ltd., Winston-Salem, NC, by facsimile and letter dated January 24, 2005. Firm initiated recall is complete.
REASON
Blood Bank devices, with an inadequate validation of the sterilization cycle, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,667,444 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
Recovered Plasma. Recall # B-0978-5.
CODE
Unit 26FZ09483.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Gulf Coast Region, Mobile, AL, by fax on December 20, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0983-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0984-5;
c) Platelets. Recall # B-0985-5;
d) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0986-5;
e) Fresh Frozen Plasma. Recall # B-0987-5;
f) Recovered Plasma. Recall # B-0988-5.
CODE
a) Units 5169910, 5176203, 5180685;
b) Units 5184908, 5190560, 6101295;
c) Unit 5176203;
d) Unit 2522363;
e) Units 5169910, 5176203, 5180685,
5184908, 6101295;
f) Unit 5190560.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on November 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were collected from a donor who was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
NY, TX, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0991-5.
CODE
Unit number: 9037033.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on October 19, 2004. Firm initiated recall is complete.
REASON
Blood product, lacking monthly quality control testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SC.

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PRODUCT
a) Red Blood Cells, Leukocytes Removed, Irradiated.
Recall # B-0996-5;
b) Platelets Leukocytes Removed. Recall # B-0997-5.
CODE
a) and b) Unit number: 19GS59253.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter, dated June 9, 2003. 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
AR, and TN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1000-5.
CODE
Unit number: 04GC13968 (Part 1).
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by telephone and by letter, dated January 26, 2005. Firm initiated recall is complete.
REASON
Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1003-5.
CODE
Unit 12KR38226.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 1, 2003 and by letter dated October 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hypereosinophilic Syndrome, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

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PRODUCT
Source Plasma. Recall # B-0977-5.
CODE
Unit: EVG005194.
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Houston, TX, by fax on January 18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Endopath 5 mm Graspers with Ratchet Handles
(product code 5DSG). Recall # Z-0724-05;
b) Endopath 5 mm Babcocks with Ratchet Handles
(product code 5BB). Recall # Z-0725-05;
c) Endopath 10 mm Anvil Graspers with Ratchet Handles
(product code 10AG). Recall # Z-0726-05;
d) Endopath 10 mm Babcocks with Ratchet Handles
(product code 10BB). Recall # Z-0727-05;
e) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code FDC21. Recall # Z-0728-05;
f) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
CK141. Recall # Z-0729-05;
g) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code FDC24. Recall # Z-0730-05;
h) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW22.
Recall # Z-0731-05;
i) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW42.
Recall # Z-0732-05;
j) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW46.
Recall # Z-0733-05;
k) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW49;
Recall # Z-0734-05;
l) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW71S.
Recall # Z-0735-05;
m) FlexTrayTM EndopathÆ GYN Tray, Kit code KD005.
Recall # Z-0736-05;
n) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG05.
Recall # Z-0737-05;
o) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG15.
Recall # Z-0738-05;
p) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB12.
Recall # Z-0739-05;
q) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB19.
Recall # Z-0740-05;
r) FlexTrayTM EndopathÆ Gastric Tray, Kit code KNG05.
Recall # Z-0741-05;
s) FlexTrayTM EndopathÆ Bariatric Tray, Kit code TBW70S.
Recall # Z-0742-05;
t) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code FDC09. Recall # Z-0743-05;
u) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code FDC45. Recall # Z-0744-05;
v) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code TDC78S. Recall # Z-0745-05;
w) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit code TDC86S. Recall # Z-0746-05;
x) FlexTrayTM EndopathÆ Gastric Tray, Kit code TGB01S.
Recall # Z-0747-05;
y) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL45.
Recall # Z-0748-05;
z) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL62.
Recall # Z-0749-05;
aa) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC06. Recall # Z-0750-05;
bb) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC12. Recall # Z-0751-05;
cc) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC15. Recall # Z-0752-05;
dd) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC20. Recall # Z-0753-05;
ee) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC61. Recall # Z-0754-05;
ff) FlexTrayTM EndopathÆ Cholecsystectomy Tray,
Kit Code TNC69. Recall # Z-0755-05;
gg) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG42.
Recall # Z-0756-05;
hh) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG73.
Recall # Z-0757-05;
ii) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG89.
Recall # Z-0758-05;
jj) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW30.
Recall # Z-0759-05.
CODE
a) V41T3E, V4224V, V42415, V42621, V42675, V42756, V4285Y,
V4297P, V42A37, V42E7H, V42G5L, V42H56, V42L17, V42L6A,
V42P1C, V42R7C, V42R89, V42U6X, V42V2E, V42X00, V42Z6X,
V43245, V4327Y, V43380, V43624, V43713 and samples;
b) V41T4F, V41W66, V41Y2L, V41Z4A, V4230C, V42553, V4272X,
V42A8K, V42E42, V42G9Y, V42M4A, V42M4C, V42P7P, V42T67,
V42V3N, V42X38, V4308K, V4333L and samples;
c) V42522;
d) V41P6R, V41T90, V41V1Y, V41W68, V4221A, V42468, V42757,
V42A8J, V42D1U, V42F2A, V42J8K, V42L8X, V42N5V, V42U69,
V42W21, V4323H, V42Z6W, V43554 and sample;
e) V4206M, V42863, V42Y5T, V4351F;
f) V4230R, V42N6G, V4346T;
g) V4276M, V42J4G, V43020, V4379J;
h) V41Y4D, V42646, V42N8A, V42VOU, V42X44;
i) V42E37, V42Y61;
j) V42215, V42F2E, V42N41, V42R8y, V4328D;
k) V41W5P, V41Y6U, V4293E, V42D2R, V42F21, V42Y06, V43029;
l) V42A83, V42R81, V42Z57, V4330Z;
m) V4290J, V42NOT, V4355L, V41W98;
n) V42P3A, V41W98;
o) V41R14, V42A8N, V2V5C, V4314E;
p) V42713, V42L31, V42E00, V42P25, V42X9Y;
q) V42X9Y, V42100, V4272Y, V42E6A, V42L52, V42P3T, V42X0R,
V42Z5A, V4324J, V4355F;
r) V42P3A;
s) V42C31, V4340G;
t) V4276A, V420ED, V42J1N, V42M3D, V42V36, V42Z2R, V4314F;
u) V42C9U;
v) V4264H, V42G5K;
w) V42Y4E, V42Z55;
x) V42G87;
y) V41Y2R, V42A66, V42E3C, V42P37, V42R52, V4328E;
z) V4275R, V42A1E, V42H2V, V42T11;
aa) V42695, V42N43, V42R7K;
bb) V4274F, V42C8R, V42H24, V42R6H, V42W3D, V42Y8E,
V4326J;
cc) V42162, V42J6X;
dd) V41Y30, V42858, V42R5E, V42U8R, V42Y01, V4372K;
ee) V42C8P, V42G43, V42X8N;
ff) V41X3K;
gg) V41T26, V42201, V42R3P, V42X4C, V4322J;
hh) V41T25, V42768, V42A65, V42F2D, V42H1U, V42N3Y;
ii) V42D70, V42X4A;
jj) V41U14, V4247A, V4292L, V42T4F, V42W45, V43096, V4361M.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery, Cincinnati, OH, by letters, dated December 14, 2004.
Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.
VOLUME OF PRODUCT IN COMMERCE
70,119 devices.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Meridian Nexus, single use. Part Numbers: C4N00D001,
15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1,
40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM,
40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1,
60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-
13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589,
60301-1304042, and 72000-75. Recall # Z-0760-05;
b) Circuit-Unilimb, Pediatric, 1M (40"), Disposable,
Clean Non-Sterile, Pediatric Anethesia Circuit,
Part Number DYNJAPF4000. Recall # Z-0761-05;
c) Unilimb Circuit 40'' Bulk, single use
Part Number 225-4400-300. Recall # Z-0762-05;
d) Meridian Nexus- Pediatric, single use Part Numbers
60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900,
40010-1, and 40111-1. Recall # Z-0763-05;
e) Portex Adult Single Limb Anesthesia Breathing Circuit,
single use, Part Numbers: 386000 and 384001.
Recall # Z-0764-05;
f) Circuit- Maching Kit, 40" Adult, 3L LPF, single use,
Part Numbers RP640F0D0 and RP660F0D0.
Recall # Z-0765-05;
g) Circuit-Nexus, Adult, single use, Part Numbers:
N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and
40301-1-2730. Recall # Z-0766-05;
h) Coaxial Rebreathing Circuit 1.5 M and 2 M, single use,
Part nubers T61500 (1.5 M) and T18116 (2 M).
Recall # Z-0767-05;
i) Circuit-Unilimb, Adult, 1M (40"), Disposable,
Clean Non-sterile, Adult Anesthesia Circuit,
Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261.
Recall # Z-0768-05.
CODE
a) Item Number 15867, Lot numbers: 562960904; 566590904;
Item Number 15880, Lot numbers: 564360904, 566230904,
570181004, 571831004, 573201004, 573201004, 575401104,
575401104, 577011104, 577011104, 578951104, 581731104,
582631204, 588431204, 588431204, 589090105, 591180105,
591180105, 593360105, 596220105, 596220105, 597890105,
597890105;
Item Number 12000-1, Lot Numbers: 581041104;
Item Number 15880-30, Lot Numbers: 573401004;
Item Number 40000-1, Lot Numbers: 568891004, 571691004,
581071104, 585381204, 589170105, 591260105, 593990105,
594930105;
Item Number 40200-1, Lot Numbers: 573461004, 573771004,
579661104;
Item Number 40301-1, Lot Numbers: 584241204;
Item Number 40301-1-13, Lot Numbers: 566290904,
569631004, 572811004, 574881104, 574881104, 578021104,
579671104, 585121204, 586721204, 588541204, 591330105,
593810105, 593810105;
Item Number 40301-1-13MM, Lot Numbers: 569211004,
583381204;
Item Number 40301-1-24, 20 per case, Lot Numbers:
564930904, 566300904, 571471004, 572821004, 574891104,
578081104, 580591104, 581691104, 583391204, 586731204,
588551204, 598410105;
Item Number 40301-1-30, Lot Numbers: 570781004,
593640105;
Item Number 40301-1ML, Lot Numbers: 574901104,
594840105;
Item Number 40302-1C24, Lot Numbers: 562980904,
566650904, 570791004;
Item Number 60000-1, Lot Numbers: 591360105;
Item Number 60201-1, Lot Numbers: 566370904, 568921004,
572491004, 573991004, 579691104, 581721104, 586761204,
590200105, 593860105, 595720105;
Item Number 60300-1, Lot Numbers: 594760105;
Item Number 60300-M, Lot Numbers: 568501004, 575711104;
Item Number 60301-1-24, Lot Numbers: 581731104;
Item Number 60301-13042M, Lot Numbers: 564510904,
568511004, 571951004, 573311004, 577181104, 580111104,
584431204, 586601204, 588621204, 589360105, 593490105,
596320105;
Item Number 60302-1HM30-70, Lot Numbers: 565830904,
581791104, 585661204, 589370105, 590210105;
Item Number 72000-50-7589, Lot Numbers: 583451204;
Item Number 72000-75, Lot Numbers: 568521004, 571511004,
571961004, 574971104, 577191104, 578131104, 578131104,
582761204, 584961204, 593870105;
Item Number 72300-1-4-30-70, Lot Numbers: 564950904,
567821004, 572841004, 578141104, 580621104, 583471204,
586771204, 589380105, 591430105, 593880105, 597180105;
Item Number 72301-1, 594880105;
Item Number C4N000D001, 568751004, 574801104, 578781104,
586301204, 591060105, 593660105, 595620105, 596830105,
596950105;
Item Number 60301-1304042, Lot Number 597570105;
b) Lot numbers: 570591004, 578361104, 580661104, 583081204,
585451204, 589720105, 593720105;
c) Lot Numbers: 578221104, 583691204, 592220105;
d) Lot Numbers: 571671004; Lot Numbers: 568901004,
581081104; Lot Numbers: 575701104;
Lot Numbers: 564430904, 580031104;
Lot Numbers: 594870105; Lot Numbers: 569701004;
Lot Numbers: 591400105;
e) Lot numbers: 551880804, 581451104, 581461104;
Lot numbers: 551890804, 600080205, 5518908004;
f) Lot Numbers: 575951104, 596600105;
Lot Number: 596610105;
g) Lot Number: 587021204, 587031204, 588371204,
591070105, 596840105; Lot Number: 575741104;
Lot Number: 596700105; Lot Number: 564460904,
566310904, 568481004, 570271004, 571911004,
573261004, 577091104, 580061104, 582711204,
588561204, 589270105, 596290105;
Lot Number: 575691104, 579871104, 585041204,
586291204;
h) Lot Number: 579811104; Lot Numbers: 572171004,
585301204;
i) Lot Number: 574481104; Lot Numbers: 570601004,
577491104, 578371104; Lot Numbers: 570701004,
589820105, 590030105, 593300105, 597460105.
RECALLING FIRM/MANUFACTURER
Recalling Firm: MMS Sales Corp, Pharr, TX, by letter on February 21, 2004.
Manufacturer: CPM De Reynosa S.A. De C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
REASON
Partial occlusion in the T-piece resulting in airway obstruction.
VOLUME OF PRODUCT IN COMMERCE
161,273 units.
DISTRIBUTION
Nationwide, Malaysia, Mexico, and New Zealand.

_______________________________
PRODUCT
a) Medline Custom Open Heart CDS Kit (non-sterile),
reorder number CDS840144A, which contains Meridian Nexus
Unilimb Rebreathing Circuit, part 40301-1-30, among
other components needed for open heart surgery;
Recall # Z-0769-05;
b) Medline Custom Anesthesia Super Circuit Adult 60 Unilimb
Kit (non-sterile), reorder number DYNJAAF6267; the kit
contains the Nexus Adult Unilimb Circuit -- 60",
part 60010-1B, along with a 3 liter latex breathing bag,
anesthesia tubing clip, suction catheter, adult
anesthesia mask, suction canister, drawstring poly bag
and poly bag. Recall # Z-0770-05;
c) Medline Custom Anesthesia Set Up Kit - Latex Free
(non-sterile), reorder number DYNJAA0078C; the kit
contains the Nexus Adult Unilimb Circuit -- 40",
part C4N000D001, along with a 3 liter latex free
breathing bag, suction catheter, adult medium anesthesia
mask, suction tubing, humid vent hme filter and poly
bag. Recall # Z-0771-05;
d) Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit
(non-sterile), reorder number DYNJAA4749; the kit
contains the Nexus Adult Unilimb Circuit - 40",
part C4N000D001, along with a 3 liter latex free
breathing bag, adult medium anesthesia mask and poly
bag. Recall # Z-0772-05;
e) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit
(non-sterile), reorder number DYNJAAF4304B; the kit
contains the Nexus Adult Unilimb Circuit -- 40",
part C4N012100, along with a 3 liter latex free
breathing bag, gas sampling coestrud and poly bag.
Recall # Z-0773-05;
f) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit
(non-sterile), reorder number DYNJAA4315; the kit
contains the Nexus Adult Unilimb Circuit - 40",
part C4N012100, along with a 3 liter latex breathing
bag, adult large anesthesia mask, gas line and poly bag.
Recall # Z-0774-05.
CODE
a) Lots 04JD2847, 04LD2995, 05AD3946, 05BD0929, 05BD4100;
b) Lots 04LD1288, 04LD1865, 05CD0012, 05CD0467;
c) Lots 04KD3355, 04KD4186, 04KD4500, 04LD1866, 04LD2479,
04LD3673, 05AD3501, 05BD0357, 05BD4129;
d) Lots 04KD1031, 05AD1865, 05CD0210;
e) Lots 04LD2997, 05AD0061, 05AD1953, 05AD4630, 05BD2119;
f) Lots 04LD3310, 05AD0830.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc, Waukegan, IL, by letters dated March 18, 2005 and March 23, 2005. Firm initiated recall is ongoing.
REASON
The procedure packs contain anesthesia/breathing circuits being recalled due to partial occlusion of the T-piece resulting in airway obstruction.
VOLUME OF PRODUCT IN COMMERCE
19,695 kits.
DISTRIBUTION
CA, AL, MN, FL, and IN.

_______________________________
PRODUCT
Staar Phaco Tubing Kit. Recall # Z-0775-05.
CODE
Lot 08345.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co, Inc, Monrovia, CA, by telephone and letter on April 7, 2004. Firm initiated recall is ongoing.
REASON
Complaints of leaking with question of sterility and risk of infection in eye.
VOLUME OF PRODUCT IN COMMERCE
114 kits.
DISTRIBUTION
CA, NV, UT, FL, and OR.

_______________________________
PRODUCT
Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability. Recall # Z-0777-05.
CODE
Serial numbers include 180053 180073 180076 180115 180136 180140 180145 180187 180204 180207 180221 180222 180224 180249 180255 180256 180260 180273 180274 180283 180294 180298 180311 180427 180433 180437 180448 180454 180458 180460 180463 180467 180469 180471 180473 180484 180486 180490 180491 180492 180509 180510 180512 180514 180517 180519 180522 180523 180526 180528 180541 180543 180549 180553 180554 180559 180560 180562 180566 180569 180576 180578 180581 180588 180593 180596 180597 180600 180601 180605 180606 180607 180608 180614 180618 180619 180626 180627 180629 180630 180631 180632 180633 180640 180643 180644 180645 180648 180655 180661 180668 180669 180670 180671 180672 180674 180679 180681 180683 180684 180690 180693 180694 180695 180696 180707 180709 180710 180715 180717 180718 180719 180720 180721 180724 180725 180726 180728 180729 180733 180735 180736 180737 180741 180745 180747 180750 180753 180756 180757 180758 180759 180761 180769 180777 180778 180780 180784 180785 180787 180792 180794 180795 180796 180797 180804 180810 180815 180816 180817 180821 180822 180823 180824 180825 180826 180827 180832 180831 180832 180833 180836 180837 180839 180841.
RECALLING FIRM
Varian Medical Systems, Inc., Palo Alto, CA, by letters on February 4, 2005. Firm initiated recall is ongoing.
REASON
Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
VOLUME OF PRODUCT IN COMMERCE
Approximately 170 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Cidexplus Solution Test Strips. Product Code: 2924, and Product Code: 2926. Recall # Z-0779-05.
CODE
Lot Numbers: 011480, 011483, 011019;
Lot numbers: 011283, 011020.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter dated March 16, 2005.
Manufacturer: Johnson & Johnson Medical, Ltd, Skipton, North Yorkshire, UK. Firm initiated recall is ongoing.
REASON
CIDEX test strips were found to pass solution below MEC.
VOLUME OF PRODUCT IN COMMERCE
3,422 cases (2 bottles per case).
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
a) Vaxcel Low Profile Port with PASV Valve and 6F
Polyurethane Catheter. CATALOG NO. 45-233.
Ref. # M001452330. Recall # Z-0780-05;
b) Vaxcel Low Profile Port with PASV valve and 8F
Silicone Catheter. Catalog No. 45-236,
Ref. # M001452360. Recall # Z-0781-05;
c) Vaxcel Low Profile Port with PASV valve and 8F
Polyurethane Catheter. CATALOG NO. 45-238,
Ref. # M001452380. Recall # Z-0782-05.
CODE
a) All lots as follows: 910022, 910022D, 923899, 973167
and 974706;
b) All lots as follows: 791486, 906776, 916194, 917025;
c) All lots as follows: 791484, 791485, 906777, 916195,
916196, 916197, 917026, 918870, 919481, 920550, 921765,
and 924851D.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letters on March 11, 2005.
Manufacturer: Boston Scientific Corp., Glens Falls, NY. Firm initiated recall is ongoing.
REASON
Potential separation of the port base from the port cover after implantation.
VOLUME OF PRODUCT IN COMMERCE
1,217 units.
DISTRIBUTION
Nationwide and South Africa.

_______________________________
PRODUCT
Architect Folate Reagent Kit, list 6C12-20 (4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests). Recall # Z-0783-05.
CODE
Lot numbers: 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by e-mail on March 11, 2005. Firm initiated recall is ongoing.
REASON
Concentrations for normal samples generated with current reagent lots of the Architect Folate assay are lower than data generated for the package insert.
VOLUME OF PRODUCT IN COMMERCE
1,419 -- 4 x 100 test kits,
742 -- 100 test kits,
575 -- 4 x 500 tests.
DISTRIBUTION
Internationally.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________
PRODUCT
DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Recall # Z-0776-05.
CODE
9850180E (expiration 08/02/2005); 9850180E/1 (expiration 08/02/2005); 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, fax or email beginning April 8, 2005.
Manufacturer: DiaSorin S.p.A. Saluggia, Italy. Firm initiated recall is ongoing.
REASON
The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).
VOLUME OF PRODUCT IN COMMERCE
2,104.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155. Recall # Z-0778-05.
CODE
Batch #50604.
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 2, 2005.
Manufacturer: Valcom, Inc, Las Vegas, NV. Firm initiated recall is ongoing.
REASON
The Configuration Transfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it, not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.
VOLUME OF PRODUCT IN COMMERCE
404 cables.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960. Recall # Z-0784-05.
CODE
Lot # 041207T, expiration date: 9-30-2005.
RECALLING FIRM
Recalling Firm: Diasorin, Inc., Stillwater, MN, by telephone and e-mail on March 16, 2005. Firm initiated recall is ongoing.
Manufacturer: Phoenix Bio-Tech Corp., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
VOLUME OF PRODUCT IN COMMERCE
14.
DISTRIBUTION
MA, CA, TX, KS, NY, and FL.

END OF ENFORCEMENT REPORT FOR May 4, 2005

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