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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October 27, 2004
04-43

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
a) "Jane Jane" Brand and "Wei Chuan" Brand Frozen Cuttlefish
Ball, 8 oz and 5 lb. bags. Recall # F-062-5;
b) "Jane Jane" and "Wei Chuan" Brand Frozen Fish Ball, 8 oz.
and 5 lb. bags. Recall # F-063-5;
c) "Jane Jane" and "Wei Chuan" Brand Frozen Shrimp Ball, 8 oz.
and 5 lb. bags. Recall # F-064-5;
d) "Jane Jane" and "Wei Chuan" Brand Pollack Fish Ball, 8 oz.
and 5 lb. bags. Recall # F-065-5;
e) "Jane Jane" and "Wei Chuan" Brand Frozen Milk Fish Ball, 8
oz. and 5 lb. bags. Recall # F-066-5;
f) "Jane Jane" and "Wei Chuan" Brand Frozen Squid Nugget Balls,
8 oz. and 5 lb. bags. Recall # F-067-5.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Wei-Chuan U.S.A., Inc., Bell Gardens, CA, by press release on July 20, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
4,549 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

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PRODUCT
Ephedrine Sulfate Injection, USP, 50 mg/mL, 10 mL Vial, For SC, IM or IV Use, Preservative Free, Pharmacy Bulk Package for Pharmacy Use Only, Rx Only, NDC Number: 66758-009-01. Recall # D-044-5.
CODE
Lot No: 012704.
RECALLING FIRM/MANUFACTURER
Parenta Pharmaceuticals, West Columbia, SC, by letter on July 8, 2004. Firm initiated recall is ongoing.
REASON
Sterility Failure.
VOLUME OF PRODUCT IN COMMERCE
83 vials.
DISTRIBUTION
FL, and SC.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) EMD Chemicals Inc. Brand MultiPharm Water, Purified,
USP/Ph Eur, 10L Cubitainer, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking. Recall
# D-040-5;
b) EMD Chemicals Inc. Brand MultiPharm Water, Purified,
USP/Ph Eur, 20L Cubitainer and 20L Poly Drum, Not for
Injection. Recall # D-041-5;
c) EMD Chemicals Inc. Brand MultiPharm Water, Purified,
USP/Ph Eur, 50L Poly Drum, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking. Recall
# D-042-5;
d) EMD Chemicals Inc. Brand MultiPharm Water, Purified,
USP/Ph Eur, 200L Poly Drum, Not for Injection, Caution:
For Manufacturing, Processing, or Repacking. Recall
# D-043-5.
CODE
a) Item# WX0006/2 -- 10L cubitainer: Lot: 3220; 3259;
4031; 4110;
b) Item# WX0006/3 -- 20L cubitainer: Lot: 3220; 3246A;
3259; 3300; 3325; 4020; 4031; 4040; 4050; 4110;
4130; 4150; 4198.
Item# WX0006/4 -- 20L poly drum: Lot: 3259; 3300;
4040; 4050;
c) Item # WX0006/5 -- 50L poly drum: Lot: 3220; 3230;
3300; 4031; 4040; 4050; 4080; 4110;
d) Item # WX0006/30 -- 200L poly drum: Lot: 3200; 3230;
3246; 3305; 3315; 3320; 3339; 3345; 4020; 4030; 4035;
4036; 4041; 4045; 4070; 4089; 4115; 4137; 4200.
RECALLING FIRM/MANUFACTURER
Emd Chemicals Inc., Gibbstown, NJ, by letters on June 8, 2004 and August 18, 2004. Firm initiated recall is ongoing.
REASON
Microbial Contamination; burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
5,724 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
ACEONÆ Tablets, (perindopril erbumine), 2 mg, 100 count bottles, Rx only, NDC 0032-1101-01. Recall # D-031-5.
CODE
Lot 3029632, Exp. 1/31/2005, 3029633, Exp. 1/31/2005, 3031235, Exp. 4/30/2005, 3031236, Exp 4/30/2005, 3032691, exp. 7/31/2005.
RECALLING FIRM/MANUFACTURER
Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on September 27, 2004. Firm initiated recall is ongoing.
REASON
Degradation Failure.
VOLUME OF PRODUCT IN COMMERCE
22,287 bottles.
DISTRIBUTION
Nationwide and PR.

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PRODUCT
a) Tiazac (diltiazem HCl) 300 mg capsules, 30, 90 and
1000 count bottles, Rx only, NDC 0456-2615-10. Recall
# D-033-5;
b) Tiazac (diltiazem HCl) 120 mg capsules, 30, 90 count
bottles, Rx only, NDC 0456-2612-90. Recall # D-034-5;
c) Tiazac (diltiazem HCl) 180 mg capsules, 30, and 1000
count bottles, Rx only, NDC 0456-2613-10. Recall
# D-035-5;
d) Tiazac (diltiazem HCl) 240 mg capsules, 30 count
bottle, Rx only, NDC 0456-2614-30. Recall # D-036-5;
e) Tiazac (diltiazem HCl) 360 mg capsules, 90 count
bottle, Rx only, NDC 0456-2616-90. Recall # D-037-5;
f) Tiazac (diltiazem HCl) 420 mg capsules, 30 and 90
count bottle, Rx only, NDC 0456-2617-90. Recall #
D-038-5;
CODE
a) Lot no./Exp. date: 010203 (1/2005), P030410 (3/2007),
P030420 (3/2007), P030801 ( 6/2007);
b) Lot no. Exp. date P030906 5/2007, P030606 5/2007;
c) Lot no. Exp. date P03A008 12/2006, P03A018 12/2006,
030302 02/2007;
d) Lot no. Exp. date P030411 3/2007;
e) Lot no. Exp. date P030411 3/2007;
f) Lot no. Exp. date P030516 4/2005, P030902 8/2005,
P030811 5/2005, P030808 5/2005.
RECALLING FIRM/MANUFACTURER
Biovail Laboratories, Inc., Carolina, PR, by letters on August 11, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
27,240.
DISTRIBUTION
Nationwide.

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PRODUCT
Pharmacist Formula, Enteric Coated Aspirin Tablets, 325 mg, 100 count bottles, OTC. Recall # D-039-5.
CODE
Lot Numbers: 2HA0359, 2HA0629, 2MA0356, 2MA0694.
RECALLING FIRM/MANUFACTURER
Leiner Health Products Llc, Carson, CA, by letter on September 29, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
25,114 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Diltiazem Hydrochloride Extended-Release Capsules,
USP, 120 mg, 90 count bottle, Rx only,
NDC 0093-5112-98. Recall # D-045-5;
b) Diltiazem Hydrochloride Extended-Release Capsules,
USP, 180 mg, 90 count bottle, Rx only, NDC 0258-
3688-90. Recall #D-046-5;
c) Diltiazem Hydrochloride Extended-Release Capsules,
USP, 300 mg, 90 count bottle, Rx only, NDC 0258-
3690-90. Recall # D-047-5.
CODE
a) Lot No. 0303T01, Exp. date 10/2005;
b) Lot No. P03579, Exp. date 11/2004;
c) Lot No, P030602.
RECALLING FIRM/MANUFACTURER
Biovail Laboratories, Inc., Carolina, PR, by letters on August 11, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
34,786.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Source Plasma. Recall # B-0039-5.
CODE
Units 86888165, 86886536, 86881807, 86891257, 86884730, 86882774, 86831673, 86828680, 86814492, 86892100, 86885843, 86883184, 86876278, 86872171, 86860963, 86859790, 86889131, 86855549, 86850490, 86880909, 86876766, 86874625, 86890724, 86887571, 86885379, 86882255, 86879811, 86877329, 86874694, 86871198, 86866941, 86864428, 86876599, 86874182, 86870924, 86868730, 86865524, 86863216, 86859608, 86856508, 86854252, 86851305, 86849630, 86846301, 86840118, 86838979, 86834674, 86832922, 86829595, 86826440, 86822190, 86820066, 86814935, 86812351, 86808422, 86806572, 86804257, 86802390, 69746536, 69743252, 69739309, 69736865, 69732409, 69730054, 86821070, 86817615, 86890878, 86888103, 86867023, 86865937, 86859936, 86857659, 86854641, 86850551, 86847742, 86845700, 86842174, 86840255, 86836951, 86834803, 86831147, 86828765, 86959216, 86816755, 86843911.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by letter dated June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screenings did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
IL.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0103-5.
CODE
Unit FE55660 - split B.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on September 7, 2004 and by letter dated September 9, 2004.
Manufacturing Firm: Heartland Blood Centers, Tinley Park,
IL. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
IL.

___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall B-0116-5.
CODE
Unit 33GN000353 (split unit).
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on August 12, 2004, and by letter dated August 18, 2004. Firm initiated recall is complete.
REASON
Blood products, which may have not met the acceptable hematocrit specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced Irradiated. Recall # B-0123-5.
CODE
Unit number 71W56510X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on April 21, 2004.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood product was not properly irradiated but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Trima Accel Automated Blood Collection System Tubing Sets
- Trima Accel LRS Platelet, Plasma, RBC Set;
- Trima Accel Platelet, Plasma, RBC & TLR Filter Set.
Recall # B-0102-5.
CODE
Lot Number 05KXXXX and 06KXXXX.
RECALLING FIRM/MANUFACTURER
GAMBRO BCT, Inc., Lakewood, CO, by letter dated July 22, 2004, and August 16, 2004. Firm initiated recall is complete.
REASON
Trima Accel Automated Blood Collection System tubing sets, that collected significantly lower yields/concentrations of platelets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50,682 sets.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0104-5;
b) Platelets. Recall # B-0105-5;
c) Recovered Plasma. Recall # B-0106-5.
CODE
a) Unit numbers LM31432, LM32389, LM31821, and LM32632;
b) Unit numbers LM30801, LM30807, LM30902, LM30918, LM31027,
c) LM31397, LM31544, LM32218, LM32212, LM32219, and LM32379;
Unit numbers LM30167, LM30173, LM30176, LM30178, LM30192,
LM30198, LM30200, LM30319, LM30323, LM30329, LM30339,
LM30344, LM30351, LM30468, LM30471, LM30474, LM30477,
LM30488, LM30491, LM30500, LM30505, LM30545, LM30555,
LM30570, LM30587, LM30801, LM30807, LM30813, LM30820,
LM30842, LM30845, LM30847, LM30853, LM30860, LM30872,
LM30875, LM30892, LM30902, LM30907, LM30910, LM30920,
LM30927, LM30933, LM31018, LM31025, LM31027, LM31187,
LM31180, LM31318, LM31339, LM31342, LM31347, LM31351,
LM31354, LM31385, LM31390, LM31392, LM31397, LM31400,
LM31411, LM31414, LM31415, LM31425, LM31432, LM31435,
LM31438, LM31441, LM31454, LG27705, LG27708, LG27710,
LG27713, LG27715, LG27717, LG27723, LM31495, LM31497,
LM31538, LM31540, LM21542, LM31544, LM31546, LM31548,
LM31549, LM31553, LM31580, LM31562, LM31573, LM31587,
LM31555, LM31565, LM31581, LM31567, LM31841, LM31845,
LM31842, LM31849, LM31816, LM31818, LM31835, LM31826,
LM31986, LM31943, LM31974, LM31948, LM31950, LM31971,
LM31989, LM31983, LM31960, LM31942, LM31956, LM31952,
LM31977, LM31993, LM31967, LM31992, LM31980, LM31990,
LM31963, LM32003, LM32011, LM32019, LM32033, LM32054,
LM32057, LM32060, LM32062, LM32079, LM32082, LM32084,
LM32085, LM32100, LM32104, LM32107, LM32110, LM32113,
LM32121, LM32123, LM32126, LM32129, LM32134, LM32135,
LM32125, LM32138, LM32167, LM32182, LM32185, LM32183,
LM32191, LM32193, LM32194, LM32196, LM32199, LM32204,
LM32115, LM32218, LM32227, LM32225, LM32229, LM32210,
LM32212, LM32219, LM32207, LM32236, LM32230, LM32250,
LM32245, LM32252, LM32249, LM32241, LM32247, LM32243,
LM32257, LM32266, LM32270, LM32275, LM32280, LM32330,
LM32343, LM32350, LM32360, LM32365, LM32369, LM32372,
LM32390, LM32399, LM32406, LM32407, LM32408, LM32413,
LM32416, LM32461, LM32462, LM32483, LM32487, LM32491,
LM32493, LM32495, LM32498, LM32501, LM32503, LM32507,
LM32510, LM32515, LM32593, LM32595, LM32596, LM32598,
LM32599, LM32604, LM32612, LM32615, LM32617, LM32620,
LM32623, LM32626, LM32628, LM32629, LM32632, LM32636,
LM32638, LM32641, LM32647, LM32650, LM32651, LM32654,
LM32656, LM32659, LM32663, LM32666, LM32668, LM32671,
LM32672, LM32675, LM32712, LM32719, LM32721, LM32726,
LM32731, LM32734, LM32752, LM32759, LM32735, LM32744,
LM32745, LM32747, LM32769, LM32772, LM32866, LM32825,
LM32838, LM32891, LM32870, LM32864, LM32819, LM32821,
LM32893, LM32879, LM32885, LM32833, LM32887, LM32869,
LM32880, LM32940, LM32910, LM32941, LM32925, LM32923,
LM32904, LM32898, LM32920, LM32917, LM32914, LM32916,
LM32902, LM32933, LM32912, LM32908, and LM32927.
RECALLING FIRM/MANUFACTURER
Lancaster General Hospital Blood Bank, Lancaster, PA, by telephone on March 22, 2004, and by letter on April 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
295 units.
DISTRIBUTION
PA, and MD.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0115-5.
CODE
Unit 71H827806.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL, by letter on August 15, 2003.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc.
Montgomery Region, Montgomery, AL. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0124-5.
CODE
Unit numbers 71L09115X, 71L478970, 71L479143, 71L479167, 71L79180, and 71L574134.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on May 25, 2004.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AL.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0125-5;
b) Platelets Pheresis, Irradiated. Recall # B-0126-5.
CODE
a) Unit numbers 71J800700 and 71J800945;
b) Unit number 71W511028.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on October 22, 2003.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam. Recall # Z-0012-05.
CODE
All serial numbers are being recalled.
RECALLING FIRM/MANUFACTURER
General Electric Med. Systems LLC, Waukesha, WI, by letter dated August 5, 2004. Firm initiated recall is ongoing.
REASON
GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in calculated EF values lower (never higher) than actual values. A low EF value could lead to a physician decision to stop needed treatment.
VOLUME OF PRODUCT IN COMMERCE
853 units.
DISTRIBUTION
Nationwide and Internationally.

___________________________________
PRODUCT
a) Stryker Navigation System - Hip Module Patient Tracker,
green; Model 6007-005-000. Recall # Z-0020-05. Recall
# Z-0020-05;
b) Stryker Navigation System - Hip Module Patient Tracker, blue;
Model 6007-010-000. Recall # Z-0021-05.
CODE
a) Serial numbers PG04-0001 through PG04-0017;
b) Serial numbers PG04-0006 through PG04-0017.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Instruments Div., Kalamazoo, MI, by letter and telephone on July 14, 2004. Firm initiated recall is complete.
REASON
The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affect the patient tracker system.
VOLUME OF PRODUCT IN COMMERCE
17.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair). Catalog No.'s IT000101-IT000148 (inclusive). Recall # Z-0022-05.
CODE
Vehicle Identification Numbers ("VIN"s): 020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302.
RECALLING FIRM/MANUFACTURER
Independence Technology LLC, Warren, NJ, by telephone beginning on August 30, 2004, and by letters on August 31, and September 1, 2004. Firm initiated recall is ongoing.
REASON
Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
VOLUME OF PRODUCT IN COMMERCE
81 chairs.
DISTRIBUTION
Nationwide, UK, Ireland, and New Zealand.

_______________________________
PRODUCT
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092. Recall # Z-0023-05.
CODE
Serial numbers 040639739, 040639849, 040639737, 040639738, 040639675, 040639674, 040639670, 040639671, 040639672, 040639716, 040639847, 040639848, 040639935, 040639936 and 040639937.
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by visit beginning on August 10, 2004. Firm initiated recall is complete.
REASON
Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
AL, CA, FL, KS, MT, OK, TX and VA.

_______________________________
PRODUCT
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent contained in Becton Dickinson's BD Gram Stain Kits and Reagents, catalog #212539. Recall # Z-0025-05.
CODE
Lots 4223220, Exp 5/28/05 4226886, Exp 5/28/05 4233156, Exp 5/28/05 4237134, Exp 6/30/05 4226882, Exp 5/28/05 4237144, Exp 6/30/05.
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Co, Sparks, MD, by fax, letter, and e-mail on September 29, 2004. Firm initiated recall is ongoing.
REASON
Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
VOLUME OF PRODUCT IN COMMERCE
8,685 bottles.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
CryoValve, Pulmonary Valve & Conduit. Recall # Z-0026-05.
CODE
Donor Number: 68668, Serial Number: 8037696, Model Number: PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on July 15, 2004. Firm initiated recall is ongoing.
REASON
A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
CA.

_______________________________
PRODUCT
SOLO-care® Plus with Aqualube, Multi-purpose solution*** AquaSoft (Private label), Multi-purpose solution***Sterile***For soft lenses, Made in Canada, Assembled in Canada, The product is distributed in units of single or twin packs containing 2 to 12 ounces of product. Recall # Z-0028-05.
CODE
All sizes, configurations and all third part branded products.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on October 1, 2004. Firm initiated recall is ongoing.
REASON
Stability tests at 24 months revealed failing results for disinfection efficacy.
VOLUME OF PRODUCT IN COMMERCE
5,913,120 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
EP Healing Abutment -- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Product Code: THA54. Recall # Z-0029-05.
CODE
Lot No. 249229.
RECALLING FIRM/MANUFACTURER
Implant Innovations, Inc., Palm Beach Gardens, FL, by e-mail, letter and telephone. Firm initiated recall is ongoing.
REASON
The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
VOLUME OF PRODUCT IN COMMERCE
216 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, and 4.0.6. Recall # Z-0030-05.
CODE
All serial numbers for versions 3.x, 4.0.5, and 4.0.6.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on October 11, 2004. Firm initiated recall is ongoing.
REASON
The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station monitoring product, 1) a delay or cessation in updating portions of th display screen: or, 2) System reset/restart.
VOLUME OF PRODUCT IN COMMERCE
11,778 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Remel Chocolate Agar, catalog # 01301, containing 15 plates/pkg, for in-vitro diagnostic use. Recall # Z-0024-05.
CODE
Lot #435902, Exp. 2004-11-04.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by telephone on September 27, 2004. Firm initiated recall is complete.
REASON
The product does not perform as intended with some quality control organisms (Haemophilus influenzae).
VOLUME OF PRODUCT IN COMMERCE
308/15-plate packages.
DISTRIBUTION
IA, KS, MO, FL, NY, IL, AR, TX, and OK.

END OF ENFORCEMENT REPORT FOR October 27, 2004

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