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U.S. Department of Health and Human Services

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Enforcement Report for August 17, 2005

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.

August 17, 2005
05-33

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Aquafarms Catfish, U.S. Farm Raised Grain Fed Catfish, breaded catfish whole, nuggets, and fillets. Sold in both food service cases (15 lb. bulk case) and retail styrofoam trays (1 lb. tray), Recall # F-584-5
CODE
All codes
RECALLING FIRM/MANUFACTURER
Aquafarms Catfish, Inc, Holdenville, OK, by telephone on July 14, 2005. Firm initiated recall is complete.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
840 lbs.
DISTRIBUTION
OK and KS

______________________________
PRODUCT
KIRIN brand Soft Drink (Tea) in 16.8 fl. oz. (500 ml), and 1.5 liter plastic bottles. Labeling is as follows: ?KIRIN ***(Japanese writing)***Since 1986*** (Japanese writing)?, Recall # F-585-5
CODE
16.8 fl. oz. bottle: code 050526/WK03;
1.5 ml bottle: various codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: NISHIN Trading Inc., Brooklyn, NY, by press release on April 1, June 1, and July 5, 2005, and letters dated June 1, 2005.
Manufacturer: Nikka Goods Co. Ltd, Kobe, Japan. Firm initiated recall is complete.
REASON
The product did not bear an ingredient statement in English and contains undeclared milk protein based on sampling and analysis by the New York State Department of Agriculture and Markets. The foreign manufacturer provided the formulation to the importer confirming the presence of milk.
VOLUME OF PRODUCT IN COMMERCE
16.8 oz. bottles: 20 cartons (24 bottles per carton);
1.5 liter bottles: 140 cartons (8 bottles per carton)
DISTRIBUTION
NY, PA, IL, MI, NJ, MA, and VA

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

_______________________________
PRODUCT
Enzyte tablets, packaged in 30 count tablet packages. Recall # F-583-5
CODE
Lot 0447K4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berkeley Premium Nutraceuticals, Inc., Cincinnati, OH, by letter on or about January 25, 2005.
Manufacturer: Garden State Nutritionals, West Caldwell, NJ. Firm initiated recall is ongoing.
REASON
The product label incorrectly identifies the total quantity of Enzyte Premium Blend as 2000 mg. The correct total quantity of the Enzyte Premium Blend is 640 mg.
VOLUME OF PRODUCT IN COMMERCE
200/30 count tablet packages
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Adrenalin Chloride Solution, (Epinephrine Nasal Solution, USP), 1mg per mL, 1 fl oz (30 mL) bottle Vasoconstrictor, For Topical Application 1:1000, Rx only, NDC 61570-300-31, Recall # D-444-5
CODE
Lot No. 005D4M, exp. 06/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on July 8, 2005.
Manufacturer: Parkdale Pharmaceuticals, Inc., Rochester, MI. Firm initiated recall is ongoing.
REASON
Defective container, split cap thread defects which may lead to a lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
16,887 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Phenazopyridine HCL Tablets, 100 mg, bottles of 8,
10, 12, and 15, Rx, NDC 49999-047-xx,
Recall # D-445-5;
b) Phenazopyridine HCL Tablets, 200 mg, bottles of 6,
9, 10, and 15, Rx, NDC 49999-176-xx,
Recall # D-446-5;
c) Propoxacet-N Tablets, (propoxyphene napsylate,
USP 100 mg and Acetaminophen 650 mg), in bottles
of 6, 10, 12, 15, 20, 30, 50, 60, 90, and 100,
Rx, NDC 49999-025-xx, Recall # D-447-5;
d) Naproxen Sodium Tablets, 550 mg., in bottles of
20, 28, 30, and 60. Rx, NDC 49999-0058-xx.
Recall # D-448-5;
e) Metronidazole Tablets, 500 mg, in bottles of 14,
21, 28 and 100, Rx, NDC 49999-095-xx,
Recall # D-449-5;
f) Indomethacin Capsules, 25 mg, in bottles of 15,
20, 30 and 90, Rx, NDC 49999-234-xx,
Recall # D-450-5;
g) Indomethacin Capsules, 75 mg, Extended-Release,
in bottles of 30, Rx, NDC 49999-0371-xx,
Recall # D-451-5;
h) APAP 300 mg/Codeine 30 mg Tablets (acetaminophen
and codeine phosphate), in bottles of 10, 12, 15,
20, 30, 50, 60 and 100, Rx, NDC 49999-060-xx,
Recall # D-452-5
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical & Surgical, Temperance, MI, by letter dated June 1, 2005.
Manufacturer: Able Laboratories Inc., S Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Lack of assurance that testing conducted for release and stability conformed to standard operating procedures (Able Labs).
VOLUME OF PRODUCT IN COMMERCE
3,325 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Antacid Tablets Ultra Strength (calcium carbonate) 500mg, 72 Chewable Tablets, Assorted Fruit, CVS pharmacy brand, Recall # D-442-5
CODE
Lot 1717487 Exp. Dec 06
RECALLING FIRM/MANUFACTURER
Guardian Drug Co., Inc, Dayton, NJ, by e-mail on May 4, 2005. Firm initiated recall is ongoing.
REASON
Mislabeled; Back panel label incorrectly states the strength of the product as Calcium carbonate 500 mg instead of actual strength of Calcium carbonate 1000 mg.
VOLUME OF PRODUCT IN COMMERCE
6,527 bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Creomulsion For Children (dextromethorphan HBc, USP) 5 mg, 4 fl. oz. (118mL) bottles, Soothing Cough Syrup, Cough Suppressant, Great Cherry Taste, Over-The-Counter, NDC 12099-0015-1, Recall # D-458-5
CODE
Lot #G01
RECALLING FIRM/MANUFACTURER
Summit Industries, Marietta, GA, by letter on June 28, 2005. Firm initiated recall is ongoing.
REASON
Tamper Evident Seals partially or completely broken.
VOLUME OF PRODUCT IN COMMERCE
808 cases -- approximately 9,696 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1708-5;
b) Recovered Plasma, Recall # B-1709-5
CODE
a) and b) Unit numbers: 4521724, 4646724
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on October 23, 2003 and October 27, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY, OK, and Switzerland

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced, Recall # B-1759-5;
b) Platelets, Leukocytes Reduced, Irradiated,
Recall # B-1760-5
CODE
a) 24FC26248, 24FC26264, 24FC26269, 24GZ14653, 24GZ14656, 24GZ14659, 24GZ14665, 24GZ14684, 24KL72602, 24KL72798, 24KJ73674, 24KL72846, 24FC26215, 24FC26220, 24FC26224, 24FC26228, 24FC26245, 24FC26275, 24FC26379, 24FC26457, 24KE54001, 24KE54005, 24KJ73673, 24KJ73675, 24KJ73677, 24KJ73678, 24KJ73682, 24KJ73691, 24KL72589, 24KL72591, 24KL72597, 24KL72599, 24KL72626, 24KL72741, 24KL72744, 24KL72748, 24KL72757, 24KL72784, 24KL72849, 24KL72853, 24FC26331, 24GZ14490, 24GZ14502, 24GZ14450, 24GZ14452, 24FC26217, 24FC26230, 24FS03390, 24GZ14666, 24GZ14676, 24KL72596, 24KL72636, 24KL72807, 24FC26420, 24FC26421, 24FC26422, 24FC26443, 24FC26444, 24FC26495, 24FS03392, 24FS03403, 24FS03409, 24GZ14473, 24GZ14742, 24GZ14795, 24GZ14801, 24GZ14804, 24KL72791, 24KS59638, 24KS59640, 24FC26340, 24FC26506, 24FC26531, 24FS03394, 24FS03433, 24FS03440, 24FS03456, 24GZ14442, 24GZ14448, 24GZ14454, 24GZ14456, 24GZ14461, 24GZ14740, 24GZ14741, 24GZ14743, 24GZ14744, 24GZ14777, 24GZ14782, 24GZ14794, 24GZ14797, 24GZ14802, 24GZ14803, 24GZ14807, 24GZ14808, 24KE54002, 24KE54004, 24KE54006, 24KG61478, 24KG61485, 24KG61486, 24KG61502, 24KG61509, 24KJ73666, 24KJ73668, 24KJ73669, 24KJ73672, 24KL72555, 24KL72570, 24KL72577, 24KL72634, 24KL72918, 24KL72922, 24KL72924, 24KL72928, 24KL72930, 24KM88195, 24KM88199, 24KM88202, 24KM88208, 24KS59644, 24KS59652, 24KS59664, 24KS59665, 24KS59667, 24KS59668, 24KS59671, 24KS59682, 24KS59683, 24KS59686, 24KY64924, 24KY64931, 24KY64944, 24KY64947, 24KL72789, 24FC26337, 24FS03452, 24GZ14445, 24GZ14496, 24GZ14499, 24GZ14752, 24GZ14799, 24KG61473, 24KJ73664, 24KL72572, 24KL72627, 24GZ14690, 24KJ73671, 24KL72912, 24KS59679, 24KS59689, 24FC26492, 24FC26525, 24FC26529, 24GZ14776, 24GZ14784, 24KG61494, 24KJ73688, 24KJ73692, 24KL72652, 24KL72808, 24KL72923, 24KL72925, 24KL72937, 24KM88200, 24KM88201, 24KS59666, 24FS03393, 24GZ14440, 24GZ14791, 24KG61496, 24KG61499, 24KJ73676, 24KJ73690, 24KL72790, 24KL72793, 24KL72795, 24KL72828, 24KL72926, 24KM88211, 24KS59651, 24KS59677, 24KS59690, 24FC26467, 24FS03396, 24FS03397, 24FS03407, 24FS03410, 24FS03446, 24GZ14439, 24GZ14443, 24GZ14444, 24GZ14446, 24GZ14449, 24GZ14513, 24GZ14673, 24GZ14675, 24GZ14678, 24GZ14692, 24GZ14753, 24GZ14767, 24GZ14780, 24GZ14783, 24GZ14792, 24KG61500, 24KG61508, 24KJ73681, 24KL72554, 24KL72556, 24KL72633, 24KL72799, 24KL72805, 24KL72816, 24KL72818, 24KL72826, 24KL72829, 24KL72857, 24KL72868, 24KL72869, 24KL72900, 24KL72913, 24KL72914, 24KL72915, 24KL72921, 24KL72932, 24KS59645, 24KS59655, 24KS59656, 24KS59658, 24KS59659, 24KS59669, 24KS59670, 24KS59672, 24KS59673, 24KS59674, 24KS59680, 24KS59688, 24KY64921, 24KY64932, 24KY64948, 24KY64949, 24KY64950, 24KY64952, 24KY64953, 24KY64955, 24FC26218, 24FC26237, 24FC26260, 24FC26261, 24FS03400, 24FS03427, 24KJ73455, 24KJ73459, 24KJ73474, 24KL72552, 24KL72605, 24KL72609, 24KL72649, 24KL72673, 24FC26234, 24FC26309, 24FC26341, 24FS03448, 24FS03519, 24FS03532, 24FS03533, 24FS03538, 24FS03539, 24FS03546, 24FS03547, 24FS03548, 24FS03565, 24FS03577, 24FS03582, 24GZ14587, 24GZ14595, 24GZ14601, 24GZ14632, 24GZ14633, 24GZ14643, 24GZ14644, 24GZ14646, 24KJ73412, 24KJ73418, 24KL72559, 24KL72569, 24KL72574, 24KL72575, 24KL72584, 24KL72586, 24KL72588, 24KL72641, 24KL72646, 24KL72655, 24KL72656, 24KL72668, 24KL72670, 24KL72672, 24KL72675, 24KL72682, 24KL72694, 24KL72699, 24KL72701, 24KL72766, 24FC26343, 24GZ14441, 24KL72721, 24KL72725, 24KJ73466, 24KJ73491, 24KL72523, 24KY64936, 24KY64957, 24KJ73416, 24KJ73422, 24KJ73429, 24KJ73436, 24KJ73442, 24KJ73464, 24KJ73478, 24KJ73504, 24KL72534, 24KL72538, 24KL72539, 24KJ73498, 24KL72517, 24KY64954, 24KY64956, 24KJ73410, 24KJ73428, 24KJ73433, 24KJ73448, 24KJ73484, 24KL72535, 24FC26156, 24KL72664, 24FC26369, 24FC26433, 24FC26435, 24FC26474, 24GZ14465, 24GZ14471, 24GZ14505, 24GZ14507, 24GZ14648, 24KG61459, 24KG61464, 24KG61466, 24KG61471, 24KG61474, 24KG61479, 24KL72735, 24KL72746, 24KL72858, 24KM88188, 24KM88205, 24FC26138, 24FC26427, 24FC26438, 24GZ14745, 24GZ14746, 24GZ14751, 24GZ14756, 24GZ14781, 24KG61477, 24KG61481, 24KG61488, 24KG61490, 24KG61492, 24KG61505, 24KL72897, 24KM88198, 24GZ14658, 24GZ14672, 24KL72800, 24FC26296, 24FC26338, 24FC26362, 24FS03555, 24FS03566, 24FS03567, 24FS03569, 24FS03576, 24GZ14468, 24GZ14474, 24GZ14477, 24GZ14481, 24GZ14482, 24GZ14485, 24GZ14491, 24GZ14493, 24GZ14494, 24GZ14495, 24GZ14497, 24GZ14498, 24GZ14500, 24GZ14506, 24GZ14508, 24GZ14509, 24GZ14677, 24GZ14688, 24GZ14691, 24GZ14693, 24GZ14694, 24KG61472, 24KG61480, 24KG61482, 24KG61483, 24KG61507, 24KL72688, 24KL72702, 24KL72724, 24KL72732, 24KL72738, 24KL72742, 24KL72743, 24KL72775, 24KM88187, 24KM88190, 24KM88203, 24FC26292, 24GZ14749, 24GZ14773, 24GZ14796, 24KJ73409, 24KJ73460, 24KJ73479, 24KJ73486, 24KJ73507, 24KL72521, 24KL72571, 24KL72679, 24KL72680, 24KL72696, 24KL72887, 24KY64928, 24FC26303, 24FC26448, 24FC26454, 24FC26471, 24FS03398, 24FS03404, 24FS03412, 24FS03415, 24FS03417, 24FS03421, 24FS03430, 24FS03513, 24FS03518, 24FS03520, 24FS03540, 24FS03541, 24FS03543, 24FS03544, 24FS03551, 24FS03553, 24FS03554, 24FS03579, 24FS03584, 24FS03585, 24FS03587, 24FS03588, 24FS03595, 24FS03599, 24GZ14669, 24GZ14674, 24GZ14680, 24GZ14682, 24GZ14685, 24GZ14686, 24GZ14761, 24KG61460, 24KG61461, 24KG61463, 24KG61470, 24KG61484, 24KG61489, 24KG61495, 24KL72553, 24KL72562, 24KL72566, 24KL72568, 24KL72576, 24KL72580, 24KL72583, 24KL72585, 24KL72594, 24KL72659, 24KL72666, 24KL72667, 24KL72809, 24KL72810, 24KL72864, 24KL72870, 24KL72878, 24KL72893, 24KM88186, 24KM88189, 24KM88194, 24KY64925, 24KY64930, 24KY64934, 24FC26219, 24FC26247, 24FC26257, 24FC26271, 24FC26272, 24FS03387, 24FS03388, 24FS03414, 24FS03441, 24FS03449, 24GZ14586, 24GZ14591, 24GZ14600, 24GZ14616, 24GZ14618, 24KL72567, 24KL72582, 24KL72629, 24KL72647, 24KL72657, 24KL72745, 24KL72754, 24KL72773, 24KL72774, 24KL72776, 24KY64926, 24KY64929, 24KY64939, 24KY64940, 24KY64941, 24FS03434, 24FS03593, 24FC26221, 24FS03525, 24FS03561, 24FC26455, 24GZ14811, 24KE54003, 24KL72875, 24KL72877, 24FC26458, 24GZ14661, 24GZ14670, 24KL72824, 24KL72860, 24FC26150, 24FC26154, 24FS03558, 24FS03559, 24FS03563, 24FS03564, 24FS03568, 24GZ14654, 24GZ14655, 24GZ14664, 24GZ14668, 24GZ14683, 24KJ73414, 24KJ73419, 24KJ73420, 24KJ73421, 24KJ73432, 24KJ73438, 24KJ73440, 24KJ73450, 24KJ73461, 24KJ73462, 24KJ73471, 24KJ73473, 24KJ73476, 24KJ73480, 24KJ73497, 24KL72495, 24KL72498, 24KL72499, 24KL72502, 24KL72506, 24KL72515, 24FC26137, 24FC26140, 24FC26155, 24FS03439, 24FS03443, 24FS03447, 24GZ14768, 24GZ14771, 24GZ14774, 24GZ14778, 24GZ14786, 24GZ14798, 24KJ73444, 24KJ73453, 24KJ73467, 24KJ73469, 24KJ73500, 24KJ73506, 24KL72503, 24KL72507, 24KL72516, 24KL72637, 24KL72639, 24KL72660, 24KG61497, 24KM88213, 24FC26342, 24FC26450, 24FS03526, 24FS03534, 24GZ14447, 24GZ14479, 24GZ14483, 24GZ14503, 24GZ14510, 24GZ14626, 24GZ14641, 24KL72663, 24KL72728, 24KL72872, 24FC26291, 24FC26306, 24FC26310, 24FS03419, 24FS03420, 24FS03429, 24FS03507, 24FS03515, 24FS03517, 24FS03537, 24FS03570, 24GZ14805, 24KJ73445, 24KJ73447, 24KJ73454, 24KJ73492, 24KJ73501, 24KJ73502, 24KJ73683, 24KJ73689, 24KL72635, 24KL72685, 24KL72690, 24KL72836, 24KL72842, 24KL72845, 24FC26270, 24FC26258, 24FC26265, 24FS03411, 24FS03413, 24FS03416, 24FS03418, 24FS03423, 24FS03425, 24FS03450, 24KY64933, 24KY64942, 24FC26376, 24FS03386, 24FS03438, 24FS03445, 24FS03454, 24FS03457, 24FS03459, 24GZ14464, 24GZ14467, 24GZ14470, 24GZ14488, 24GZ14489, 24GZ14492, 24GZ14501, 24GZ14504, 24GZ14511, 24GZ14606, 24GZ14613, 24GZ14617, 24GZ14634, 24GZ14637, 24GZ14642, 24KJ73470, 24KJ73472, 24KL72642, 24KL72650, 24KL72654, 24KL72658, 24KL72737, 24KL72750, 24KL72751, 24KL72768, 24KY64923, 24KY64943, 24FC26240, 24FC26239, 24FC26225, 24FC26246, 24KL72595, 24FC26301, 24FS03522, 24FS03545, 24FS03600, 24KL72494, 24KL72501, 24KL72558, 24KL72579, 24KL72695, 24FS03511, 24FS03557, 24FS03560, 24FS03575, 24KL72674, 24KL72704, 24FC26297, 24FS03408, 24FS03422, 24FS03426, 24FS03508, 24FS03510, 24FS03549, 24FS03550, 24FS03556, 24FS03571, 24FS03578, 24FS03581, 24FS03583, 24FS03586, 24FS03596, 24FS03598, 24KL72628, 24KL72676, 24KL72681, 24KL72698;

b) 24KG61475, 24KL72496, 24KL72509, 24KM88192, 24KM88193, 24KM88206, 24FC26275, 24KL72631, 24KL72632, 24KL72686,
24KL72689, 24KL72723, 24GZ14747, 24GZ14748, 24GZ14758,
24GZ14763, 24GZ14766, 24FC26363, 24FC26373, 24FC26424,
24FC26437, 24FC26440, 24FC26460, 24FC26462, 24FC26463,
24FC26468, 24FC26470, 24GZ14747, 24GZ14748, 24GZ14754,
24GZ14758, 24GZ14763, 24GZ14766, 24KJ73684, 24KJ73686,
24KL72762, 24KL72767, 24KL72772, 24KL72786, 24KL72788,
24KL72794, 24KL72796, 24KL72837, 24KL72841, 24KL72850,
24KL72851, 24KL72859, 24KL72867, 24KL72908, 24FC26146,
24FC26442, 24KL72812, 24KL72815, 24KL72832, 24KM88191,
24KM88197, 24KM88209, 24FC26153, 24FC26343, 24FC26446,
24GZ14441, 24GZ14765, 24GZ14770, 24GZ14775, 24GZ14779,
24KG61467, 24KG61468, 24KG61501, 24KJ73411, 24KJ73413,
24KL72500, 24KL72505, 24KL72526, 24KL72803, 24KL72813,
24KL72825, 24KL72834, 24KL72843, 24KM88212, 24FC26452,
24FC26464, 24FC26493, 24FC26501, 24GZ14594, 24GZ14597,
24GZ14602, 24GZ14625, 24KL72801, 24KL72811, 24KL72820,
24KL72822, 24KL72700, 24FC26151, 24KL72598, 24KL72730,
24KL72740, 24FS03437
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter dated March 9, 2004 and May 4, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
828 units
DISTRIBUTION
IN, KY, and NC

_______________________________
PRODUCT
Source Plasma, Recall # B-1793-5
CODE
Unit numbers: 7020256254, 7020255729, 7020253793,
7020253285, 7020251063, 7020249722, 7020247726, 7020247045,
7020246408, 7020245865, 7020245330, 7020243382, and
7020241838
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Aurora, CO, by facsimile on March 13, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had close contact with an individual with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
UK

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1794-5
CODE
Unit number: 100438693 (split)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated December 30, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1831-5
CODE
Unit number: 107363513
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on September 24, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1838-5
CODE
Unit number: 10741-0855
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 29, 2002. 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
AZ

_______________________________
PRODUCT
a) Platelets, Recall # B-1839-5;
b) Fresh Frozen Plasma, Recall # B-1840-5
CODE
a) and b) Unit number: 10737-7470
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on September 23, 2002. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1841-5;
b) Recovered Plasma, Recall # B-1842-5
CODE
a) and b) Unit number: 4966216
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 27, 2004 and November 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1843-5;
b) Recovered Plasma, Recall # B-1844-5
CODE
a) and b) Unit number: 5219605
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on February 23, 2005 or February 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1846-5;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-1847-5;
c) Fresh Frozen Plasma, Recall # B-1848-5
CODE
a) and c) Unit numbers: 4899331, 4899348, 4899349;
b) Unit number: 7600400A
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, USC Blood Donor Center, Los Angeles, CA, by letter dated October 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose health history regarding exposure to SARS was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1852-5
CODE
Unit number: 030GV15461
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on April 21, 2005, and by letter on April 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to an unacceptable hemoglobin value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1853-5
CODE
Unit number: 030GY42902
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on April 13, 2005, and by letter on April 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to an unacceptable hemoglobin value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1854-5
CODE
Unit number: 5555555
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on March 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-1855-5
CODE
Unit number: CCRPYH, CCRQVT, CCRSFR
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. (formerly Aventis Bio-Services, Inc.), Kansas City, MO, by letter dated October 25, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1857-5;
b) Fresh Frozen Plasma, Recall # B-1858-5
CODE
a) and b) Unit number: FS13821
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter dated October 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1859-5
CODE
Unit number: 4971292
RECALLING FIRM/MANUFACTURER
Oakland Blood Institute, Oklahoma City, OK, by facsimile on November 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1860-5
CODE
Unit number: 4663798
RECALLING FIRM/MANUFACTURER
Oakland Blood Institute, Oklahoma City, OK, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1861-5
CODE
Unit number: 4880406
RECALLING FIRM/MANUFACTURER
Oakland Blood Institute, Oklahoma City, OK, by facsimile and telephone on April 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1862-5
CODE
Unit number: 4917414
RECALLING FIRM/MANUFACTURER
Oakland Blood Institute, Oklahoma City, OK, by telephone and facsimile on June 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1872-5;
b) Platelets, Recall # B- 1873-5
CODE
a) and b) Unit number: J56259
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on May 20, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

_______________________________
PRODUCT
Platelets, Recall # B-1874-5
CODE
Unit number: T69401
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by telephone on March 16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from whole blood 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-1876-5
CODE
Units G44718020, G44934020, G45424020, G45681020, G46179020, G46520020, and G47092020
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, McAllen, TX, by facsimile on August 8, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
UK

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1880-5
CODE
Unit number: 22FC24880
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on April 20, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Plasma that tested positive for Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1881-5   
CODE
Unit number: 22FX12128
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on March 25, 2005 and by letter on March 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-1882-5
CODE
Unit number: 22KT72102
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on March 31, 2005 and by letter on April 11, 2005. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1887-5
CODE
Unit number: 4891935
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on October 22, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Source Plasma, Recall # B-1889-5
CODE
Unit numbers: 10003456, 10003856, 10004003, 10011228, 10011323, 10011895, 10012303, 10012601, 10013335, 10014223, 10014414, 10014853, and 10018191
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Allentown, PA, by facsimile on February 24, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in a high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1890-5
b) Fresh Frozen Plasma, Recall # B-1891-5;
c) Recovered Plasma, Recall # B-1892-5
CODE
a) Unit numbers: 27GC79220 and 27LM25060;
b) Unit number: 27LM25060;
c) Unit numbers: 27GC79220 and 27LH05625
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone, electronic mail, and/or letters on May 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WV, PA, KY, CA, and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1894-5
CODE
Unit number: 5232181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on March 2, 2005.
Manufacturer: Oklahoma Blood Institute, Oklahoma City, OK, Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Source Plasma, Recall # B-1895-5
CODE
CCMQGH, CCMQHM, CCMQJD, CCMQKP, CCMQLC, CCMQMN, CCMQNW, CCMQPH, CCMQVL, CCQQGC, CCQRCB, CCQRCW, CCQRFK, CCQRLX, CCQRMW, CCQRTS, CCQRVW
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. (formerly Aventis BioServices, Inc.), Kansas City, MO, by letter dated November 22, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1898-5
CODE
Unit number: 4849483
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 12, 2004, April 11, 2005 and May 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1899-5
CODE
Unit number: 4808835
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on March 26, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Apheresis Leukoreduced, Recall # B-1900-5
CODE
Unit numbers: 4837512 (1), 4837512 (2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on September 18, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-1901-5
CODE
Unit number: 4911157
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on October 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-1902-5;
b) Platelets, Recall # B-1903-5
CODE
a) Unit number: 4762386;
b) Unit number: 4762686
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by fax on January 9, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and TX

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1905-5
CODE
Unit number: LR05295
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by facsimile dated October 15, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1906-5
CODE
Unit numbers: 21KP63912 (double collection), 21KP63913, 21KP63914, 21KP63916, 21KP63918, 21KP63919, 21KP63920, 21KP63932, 32GP32380, 32GP32381, 32KP43401, 32KP43403, 32KP43404
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated April 20, 2005. Firm initiated recall is complete.
REASON
Platelets remained in transit for greater than 24 hours.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
PA and NJ

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1907-5
CODE
Unit numbers: LS05938 and LW12106
RECALLING FIRM
Central Blood Bank, Pittsburgh, PA, by facsimile on May 2 and 9, 2005. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1908-5
CODE
Unit number S23058
RECALLING FIRM
HCSC Blood Center, Bethlehem, PA, by letter on February 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1910-5
CODE
Unit number: 06FS80169
RECALLING FIRM
The American National Red Cross, Southern California Region, Pomona, CA, by letter on March 5, 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
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-1911-5
CODE
Unit numbers: WNO003696, WNO003728, WNO004919, WNO004998, WLG001345, WLG003716, WLG003813, WLG004017, WLG004738, WLG004986, WLG005097, WLG005405, WLG005642, WLG005733, WLG006583, and WLG006940
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Wilmington, DE, by facsimile on April 13, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Source Plasma, Recall # B-1913-5     
CODE
Units E49817, D46747, D45977, D45631, D45415, D45222, 7050064565, 7050064322, 7050062428, 7050062151, 7050042760, 7050038957, 7050037175, 7050036984, 7050036590, 7050036071, 7050034878, 7050034605, 7050034086, 7050032552, 7050032408, 7050032108, 7050031445, 7050031289, 7050030815, 7050029978, 7050029469, 7050029288, 7050029023, 7050028351, 7050025998, and 7050025843
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Ft. Collins, CO, by facsimile on September 9, 1999. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
NC, NY, and UK

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1914-5;
b) Recovered Plasma, Recall # B-1915-5
CODE
a) and b) Unit number: 4957025
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on December 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1916-5;
b) Platelets, Recall # B-1917-5;
c) Fresh Frozen Plasma, Recall # B-1918-5;
d) Recovered Plasma, Recall # B-1919-5
CODE
a) Unit numbers: 4154330, 4309741, and 4523456;
b) Unit numbers: 4309741 and 4523456;
c) Unit number: 4523456;
d) Unit numbers: 4154330 and 4309741
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on May 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, TX, FL, and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1920-5
CODE
Unit number: 362662289
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by telephone on November 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-1921-5
CODE
Unit numbers: 370008976, 370006315, 370005789, 370005402, 370005064, 370004487, 370004322, and 370003952
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Toledo, OH, by facsimile on December 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1922-5;
b) Platelets, Recall # B-1923-5
CODE
a) and b) Unit number: 6811653
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Inc, Elyria, OH, by letter dated May 6, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Source Plasma, Recall # B-1925-5
CODE
Unit numbers: VL182598 and VL182340
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Shreveport, LA, by facsimile on February 6, 2004. Firm initiated recall is complete.
REASON
Blood products that had incomplete testing for hepatitis B virus (HBV) were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1926-5
CODE
Unit number: 9040009
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on October 11, 2004. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1927-5
CODE
Unit number: 12FJ27230
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC by telephone on July 10, 2003, and by letter on July 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1928-5
CODE
Unit number: 12W01663
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC by telephone on March 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit that had exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1935-5;
b) Recovered Plasma, Recall # B-1936-5
CODE
a) and b) Unit number: 04N38074
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, AL, by telephone, letter, and electronic mail on May 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history interview did not have documentation to an answer to a medical history question related to Creutzfeldt-Jakob disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and ME

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1937-5
CODE
Unit number: 04GP59204
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, AL, by telephone and letter on April 25, 2005. Firm initiated recall is complete.
REASON
Blood product, that tested positive for microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1938-5
CODE
Unit number: 04KC31090 (distributed as two split units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, AL, by telephone and letter on May 7, 2005. Firm initiated recall is complete.
REASON
Blood products, that tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1941-5;
b) Platelets, Recall # B-1942-5;
c) Fresh Frozen Plasma, Recall # B-1943-5
CODE
a), b), and c) Unit number: LR58591
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reported to having tested positive for the human immunodeficiency virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1825-5
CODE
Unit numbers: 107386501 and 107386507
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated November 22, 2002. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1845-5
CODE
Unit numbers: 10742-6175, 10742-7315, 10742-8785, 10742-9758, 10743-0086, 10742-6230, 10743-0577
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated January 3, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1850-5;
b) Cryoprecipitated AHF, Recall # B-1851-5
CODE
a) and b) Unit number: 30GS47541
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on April 14, 2005, and by letter on April 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose body temperature was not properly determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and NY

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1856-5
CODE
Unit number: 20LM96454
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated November 9, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Recovered Plasma, Recall # B-1863-5
CODE
Unit numbers: 20GS20766, 20GM75090, 20GC16624
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated January 7, 2003.
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood products, stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1866-5;
b) Platelets, Recall # B-1867-5;
c) Platelets Pheresis Leukocytes Reduced,
Recall # B-1868-5;
d) Fresh Frozen Plasma, Recall # B-1869-5
CODE
a) Unit numbers:
9035976, 9035977, 9035978, 9035979, 9035980, 9035981, 9039967, 9036701, 9036702, 9036704, 9037080, 9037081, 9037082, 9037083, 9037084, 9037085, 9037086, 9037087, 9037088, 9037089, 9037090, 9037091, 9037082, 9039606, 9039607, 9037496, 9037497, 9038014, 9038015, 9038016, 9038018, 9038019, 9038020, 9038021, 9038022, 9038023, 9039326, 9038128, 9038129, 9038130, 9038131, 9038132, 9038133, 9034463, 9039757, 9034489, 9034490, 9035287, 9035288, 9035289, 9035290, 9035291, 9035292, 9035293, 9035294, 9035295, 9035296, 9039823, 9035886, 9035887, 9035888, 9035889, 9035880, 9035891, 9035892, 9035893, 9035894, 9035895, 9035896, 9035963, 9035964, 9035965, 9035967, 9035968, 9035969, 9035970, 9035971, 9035972, 9035973, 9035974, 9035975, 9038134, 9036384, 9038159, 9038160, 9038161, 9038162, 9038163, 9038164, 9038165, 9038166, 9038167, 9038168, 9039355, 9038169, 9038170, 9038171, 9038172, 9038173, 9038175, 9038176, 9038177, 9038178, 9038179, 9038180, 9039358, 9038190, 9038191, 9038193, 9038194, 9038195, 9038255, 9038256, 9038257, 9038363, 9038516, 9038517, 9038518, 9038519, 9038520, 9038521, 9038522, 9038524, 9038525, 9038526, 9038735, 9038736, 9038737, 9038738, 9038739, 9038740, 9038741, 9038742, 9038743, 9038744, 9038745, 9038746, 9038747, 9038748, 9039006, 9038749, 9038750, 9038752, 9038753, 9038754, 9038755, 9039011, 9036424, 9038779, 9038780, 9038781, 9038782, 9038783, 9039022, 9038843, 9038844, 9038845, 9038846, 9038847, 9038848, 9038849, 9038850, 9038851, 9038852, 9038853, 9038854, 9038855, 9038856, 9038857, 9038858, 9038859, 9038860, 9038861, 9038862, 9038863, 9038864, 9038865, 9038866, 9038867, 9038868, 9038870, 9038871, 9038872, 9038873, 9038874, 9036439, 9036440, 9039076, 9040023, 9040024, 9040025, 9040026, 9040027, 9040028, 9040029, 9040030, 9039078, 9039080, 9039081, 9040031, 9040032, 9040033, 9040035, 9040036, 9040037, 9040038, 9040039, 9040040, 9040042, 9039092, 9040102, 9040103, 9040104, 9040105, 9040106, 9040107, 9040108, 9040109, 9010110, 9040111, 9040112, 9040113, 9040114, 9040115, 9040116, 9036444, 9036445, 9036446, 9039097, 9039098, 9040135, 9040136, 9040137, 9040139, 9040140, 9040141, 9040142, 9040143, 9040144, 9040145, 9040146, 9040167, 9040168, 9040169, 9040170, 9040171, 9040172, 9040173, 9040174, 9040175, 9040176, 9040177, 9040178, 9040179, 9040180, 9036465, 9036466, 9039149, 9040342, 9040343, 9040344, 9040345, 9040346, 9040347, 9040348, 9040349, 9040350, 9040351, 9040352, 9040353, 9036467, 9039150, 9040354, 9040355, 9040356, 9040357, 9040358, 9040359, 9040360, 9036474, 9036475, 9036476, 9039198, 9040549, 9040550, 9040551, 9040552, 9040553, 9040554, 9040555, 9040556, 9040557, 9040558, 9040559, 9041014, 9041015, 9041016, 9041017, 9041018, 9041035, 9041019, 9041021, 9041022, 9041023, 9041024, 9041025, 9044849, 9041342, 9041343, 9041344, 9041345, 9041346, 9041347, 9041348, 9044886, 9044889, 9041361, 9041362, 9041363, 9041364, 9041365, 9041366, 9041367, 9041368, 9041369, 9041370, 9041371, 9041372, 9041373, 9041375, 9041376, 9041055, 9041056, 9041553, 9041554, 9041555, 9041556, 9041557, 9041558, 9041559, 9044965, 9041062, 9041063, 9041610, 9041611, 9041612, 9041613, 9041614, 9041615, 9041616, 9041617, 9041618, 9041619, 9041620, 9041621, 9041622, 9041623, 9044987, 9044988, 9041910, 9041911, 9041912, 9041913, 9041914, 9041915, 9041916, 9041917, 9041918, 9041919, 9041920, 9041921, 9041922, 9041923, 9041924, 9041925, 9041926, 9044604, 9041095, 9041096, 9042069, 9042070, 9042071, 9042072, 9042073, 9042074, 9042075, 9042076, 9042077, 9042078, 9042079, 9042080, 9042081, 9042082, 9044637, 9044638, 9041097, 9042083, 9042084, 9042085, 9042086, 9042087, 9042088, 9042089, 9042090, 9042091, 9042092, 9042093, 9042094, 9042095, 9042097, 9042098, 9044644, 9042099, 9042100, 9042101, 9042102, 9042103, 9042104, 9042105, 9042106, 9042107, 9042108, 9042109, 9042611, 9042612, 9042613, 9042615, 9042616, 9042618, 9142619, 9044332, 9044337, 9044338, 9044339, 9042110, 9042111, 9042169, 9042170, 9042171, 9042172, 9042173, 9042174, 9042175, 9042176, 9044678, 9044682, 9042286, 9042287, 9042288, 9042289, 9042290, 9042291, 9042292, 9042294, 9042295, 9042296, 9044726, 9041104, 9042297, 9042298, 9042299, 9042300, 9042301, 9044731, 9044731, 9038827, 9042605, 9042606, 9042607, 9042608, 9042609, 9042610, 9035559, 9035560, 9035561, 9035562, 9035563, 9035564, 9035565, 9035566, 9055567, 9035568, 9035569, 9035570, 9035571, 9035572, 9036260, 9035288, 9040355
b) Unit numbers:
9037088, 9037089, 9037090, 9037091, 9038014, 9038015, 9038016, 9038017, 9038018, 9038019, 9038020, 9038021, 9038022, 9038023, 9035287, 9035288, 9035886, 9035888, 9035891, 9035892, 9035893, 9035963, 9035964, 9035965, 9035967, 9035968, 9035969, 9038159, 9038160, 9038161, 9038162, 9038163, 9038164, 9038165, 9038166, 9038167, 9038168, 9038170, 9038171, 9038363, 9038516, 9038517, 9038518, 9038519, 9038520, 9038521, 9038522, 9038524, 9038737, 9038738, 9038739, 9038740, 9038741, 9038742, 9038743, 9038749, 9038750, 9038753, 9038754, 9038770, 9038780, 9038781, 9038782, 9038783, 9038843, 9038844, 9038845, 9038847, 9038848, 9038849, 9038850, 9038851, 9038852, 9038853, 9038854, 9040023, 9040024, 9040025, 9040026, 9040031, 9040032, 9040033, 9040035, 9040036, 9040037, 9040038, 9040039, 9040102, 9040103, 9040104, 9040105, 9040106, 9040107, 9040108, 9040109, 9040111, 9040112, 9040113, 9040114, 9040115, 9040135, 9040136, 9040137, 9040139, 9040167, 9040168, 9040169, 9040170, 9040171, 9040172, 9040173, 9040174, 9040175, 9040176, 9040343, 9040344, 9040345, 9040346, 9040347, 9040348, 9040349, 9040350, 9040351, 9040352, 9040353, 9040354, 9040355, 9040358, 9040359, 9040549, 9040550, 9040551, 9040552, 9040553, 9040554, 9040555, 9040556, 9040557, 9040558, 9040559, 9035559, 9355560, 9035561, 9035562, 9035563, 9035564, 9035565, 9039866, 9039867, 9040355
c) Unit numbers:
9039963, 9039964, 9039965, 9039966, 9039967, 9039606, 9039607, 9039326, 9039327, 9039328, 9039758, 9039759, 9039824, 9039825, 9039947, 9039948, 9039949, 9039352, 9039353, 9039354, 9039355, 9038169, 9038180, 9039356, 9039443, 9039444, 9039006, 9039007, 9039008, 9039009, 9039010, 9039011, 9039020, 9039021, 9039022, 9039036, 9039037, 9039038, 9039075, 9039077, 9039079, 9039080, 9039081, 9039092, 9039095, 9039096, 9039097, 9039098, 9039106, 9039107, 9039148, 9039149, 9039150, 9039196, 9039197, 9039198, 9044845, 9044846, 9044847, 9044848, 9044849, 9044850, 9044886, 9044887, 9044888, 9044889, 9044895, 9044896, 9044897, 9044898, 9044899, 9044962, 9044963, 9044964, 9044965, 9044966, 9044967, 9044968, 9044986, 9044987, 9044988, 9044604, 9044605, 9044606, 9044636, 9044639, 9044640, 9044641, 9044642, 9044643, 9044644, 9044646, 9044647, 9044648, 9044332, 9044337, 9044338, 9044339, 9044649, 9044650, 9044678, 9044680, 9044681, 9044682, 9044683, 9044684, 9044725, 9044726, 9044727, 9044728, 9044729, 9044730, 9044731, 9044732, 9044733, 9044682
d) Unit numbers:
9039963, 9039965, 9039967, 9037082, 9037083, 9037085, 9037089, 9037090, 9037091, 9037092, 9039606, 9039607, 9038014, 9038015, 9038016, 9038018, 9038019, 9038020, 9038021, 9038022, 9038023, 9039327, 9039328, 9039757, 9039758, 9035287, 9035288, 9035289, 9035290, 9035291, 9035292, 9039823, 9039824, 9039825, 9035889, 9035892, 9035893, 9039947, 9035964, 9035965, 9038159, 9038160, 9038161, 9038162, 9038163, 9038166, 9038167, 9038168, 9039352, 9039353, 9039354, 9038170, 9038171, 9038176, 9038179, 9038180, 9039356, 9039357 (2 units), 9038524, 9039443, 9039444, 9038738, 9038742, 9038744, 9039008, 9039009, 9038752 (2 units), 9039011, 9038781, 9039020, 9039021, 9039022, 9038843, 9038847, 9038849, 9038851, 9038868, 9038871, 9038872, 9039036, 9039037, 9039038, 9039075, 9040023, 9040025, 9040026, 9039077, 9039079, 9039080, 9040031, 9040033, 9040035, 9040036, 9040037, 9040038, 9040039, 9040102, 9040103, 9040105, 9040107, 9040108, 9040109, 9040110, 9040111, 9040113, 9040115, 9039096, 9039097, 9039098, 9040135, 9040136, 9040137, 9040139, 9039107, 9040167, 9040168, 9040171, 9040172, 9040173, 9040174, 9040175, 9040176, 9039149, 9039150, 9039196, 9039198, 9040549, 9040550, 9040551, 9040552, 9040553, 9044895, 9044896, 9044897, 9044898, 9044899, 9044962, 9044963, 9044964, 9044966, 9044967, 9044968, 9044986, 9044987, 9044988, 9041911, 9041912, 9041914, 9041915, 9041916, 9041917, 9041920, 9041921, 9041922, 9041923, 9041925, 9041926, 9044604, 9044605, 9044606, 9042069, 9042070, 9042073, 9042074, 9042076, 9042077, 9042078, 9042079, 9042080, 9042081, 9044637, 9044638, 9044639, 9044640, 9044641, 9042084, 9042085, 9042086, 9042088, 9044642, 9044643, 9042090, 9042091, 9042093, 9042094, 9042095, 9042097, 9044644, 9044646, 9044648, 9042099, 9042100, 9042101, 9042102, 9042103, 9042104, 9042105, 9042106, 9042107, 9042611, 9042612, 9042613, 9042615, 9042616, 9042618, 9042619, 9044332, 9044337, 9044338, 9044339, 9042110, 9042111, 9044649, 9044650, 9044678, 9044680, 9044682, 9044684, 9044725, 9044726, 9044727, 9044728, 9044729, 9044730, 9044731, 9044732, 9044733, 9042605, 9042606, 9042608, 9042609, 9042610, 9039867, 9035288, 9044682
RECALLING FIRM/MANUFACTURER
East Jefferson General Hospital Blood Bank, Metairie, LA, by facsimile dated October 22, 2003. Firm initiated recall is complete.
REASON
Blood products, improperly tested for the HIV-1 p24 antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
994 units
DISTRIBUTION
LA and FL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1870-5;
b) Red Blood Cells, Irradiated, Recall # B-1871-5
CODE
a) Unit numbers: 19GF37022, 19LF03651, 19GR15343, 19GG57893,
19GW19065, 19GF35499, 19GZ23134, and 19GF37152;
b) Unit numbers: 19GG57910, 19LC07509, 19GJ36421,
19GJ36415, 19GW18917, 19LY18770, 19GF36644,
19GF37156, 19GW18623, 19GH15310, 19GS18251,
19GF36403, 19GW18889, 19GF36660, 19GF36654,
19GW18893, 19LF03605, 19GF36802, and 19GF37005
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Nashville, TN, by telephone on June 6, 1997 and by letter dated June 17, 1997. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
TN and KY

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1875-5
CODE
Unit number: T16651
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI, by facsimile on May 10, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1877-5
CODE
Unit numbers: 38FV35204, 38FV35205 (double unit) 38FV35213 (double unit), 38FV35216 (double unit), 38FV35224 (double unit) and 38FV35240 (double unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Fort Wayne, IN, by telephone on April 26, 2005 and by letters dated April 28 and May 31, 2005. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Indiana

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1886-5
CODE
Unit number: 007FH17315
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable high hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1888-5
CODE
Unit number: 3423104
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on June 7, 2005 and by letter dated June 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as leukocytes reduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1893-5
CODE
Unit number: 182182844
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone on November 30, 1998. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from whole blood in which the associated Red Blood Cells were found to be contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WY

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1896-5
CODE
Unit number: 4901354
RECALLING FIRM
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood unit with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Platelets, Recall # B-1897-5
CODE
Unit number: 4833208
RECALLING FIRM
Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 28, 2004.
Manufacturer: Southwest Oklahoma Blood Institute, Lawton, OK. Firm initiated recall is complete.
REASON
Blood product, prepared from a whole blood unit with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1904
CODE
Unit numbers: 027KJ00862, 027LQ20319
RECALLING FIRM
American Red Cross Blood Services, Johnstown, PA, by telephone on March 30, 2005, and by letter dated April 4, 2005. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for the presence of red cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1909-5
CODE
Unit number: 36266-2761
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ventura, CA, by telephone on October 24, 2002. Firm initiated recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe
Adaptor; (Catalog Number: T2288), Recall # B-1912-5
CODE
Lot Number: 108779
RECALLING FIRM/MANUFACTURER
Charter Medical Limited, Winston-Salem, NC, by telephone on June 8, 2005 and June 10, 2005, and by letter on June 20, 2005. Firm initiated recall is complete.
REASON
Transfer packs, missing relevant labeling information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
485 units
DISTRIBUTION
FL, IL, OH, and VA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1924-5
CODE
Unit number: 0708722
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Inc., Elyria, OH, by letter dated June 27, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Polystan Coronary Cannula Balloon Tip( Cardiopulmonary bypass vascular catheter), Recall # Z-1061-05
CODE
Lot numbers: 162119; 162572; 163299; 164050; 165934; 167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618; 186149; 187100; 188865
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc, Bridgewater, NJ, by letter on May 20, 2005.
Manufacturer: Jostra Ag, Hirrlingen, Germany. Firm initiated recall is ongoing.
REASON
Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter?s FDA approval status.
VOLUME OF PRODUCT IN COMMERCE
890 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER 7F; INTRADYN TEAR-AWAY INTRODUCER 8F; INTRADYN TEAR-AWAY INTRODUCER 9F; INTRADYN TEAR-AWAY INTRODUCER 10F; INTRADYN TEAR-AWAY INTRODUCER 11F; INTRADYN TEAR-AWAY INTRODUCER 12F; INTRADYN TEAR-AWAY INTRODUCER 15F; INTRADYN TEAR-AWAY INTRODUCER 16F; 23HI120 12F X 23CM HEMO INTRO; 23HI130 13F X 23CM HEMO INTRO; 30STA8 8FR X30CM T/A INTRO -NJ*; 30STA9 9FR X 30CM SHEATH -NJ*; 30STA10 10FR X 30CM T/A INTRO -NJ*; 30STA12 12FR X 30CM T/A INTRO -NJ*; 30STA16 16FR X 30CM SHEATH; BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; 45STA9 45CM T/A INTRODUCER -NJ*; LUTHER 6F - T/A ASSM CLIP; 10HI14038 14F X 11CM HEMO W/WI; BOSTON SCI 12FX 21.35 DIL/SHEATH; 10HI12038 12F X 11CM HEMO W/WI; 10HI13038 13F X 11CM HEMO W/WI; BOSTON SCI 9F X 9.54 STEP DIL/SH; BOSTON SCI 9F X 15.44 STEP DIL/SH; BOSTON SCI 9F X 21.35 STEP DIL/SH; BOSTON SCI 11F X 9.54 STEP DIL/SH; BOSTON SCI 11F X 15.44 STEP DIL/SH; BOSTON SCI 12F X 9.54 DIL/SHEATH; BOSTON SCI 12F X 15.44 DIL/SHEATH; BOSTON SCI 14F X 9.54 DIL/SHEATH; BOSTON SCI 14F X 15.44 DIL/SHEATH; BOSTON SCI 16F X15.44 DIL/SHEATH; 30STA15 15FR LONG TA INTRODUCR; 30STA11 11FR LONG TA INTRODUCR -NJ*; CARDIAC PACEMAKER T/A SHEATH; 14FR TA DILATOR/SHEATH-BULK; 12FR INTRODUCER TEAR AWAY BNS; 12FR TA DIL/SHEATH LC; 8FR TA SHEATH; 10FR TA SHEATH; 16FR TA SHEATH; 8/10FR LOCK T/A INTRO STEPPED; 6FR T/A DILATOR/SHEATH; 6FR LOCKING T/A INTRO ASSY; 14FR X 143MM LOCKING T/A INTRODUCERS; PTFE 4.5 FR BARD ACCESS INTRODUCERS; PTFE 6.0 FR BARD ACCESS INTRODUCERS; 7F LOCKING INTRO SYSTEM; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; 9 FR (0/S) LOCKING INTRO SYSTEM; 12F LOCKING INTRO SYSTEM; 14FR LOCKING T/A INTRODUCER; 10FR X 18 CM LOCKING T/A INTRODUCER; 14FR X 12MM LOCKING T/A INTRODUCER; 10.5FR X 18CM LOCKING T/A INTRODUCER; 10FR X 23CM LOCKING T/A INTRODUCER; 10FR LOCKING TEAR-AWAY INTRODUCERS; INTRADYN TEAR-AWAY INTRODUCER 10.5F; 30STA14 14FR X 30CM T/A INTRO -NJ*; BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY; CELSA 5FR LOCKING T/A INTRODUCER; CORDIS 4" BLUNT TIP T/A SHEATH; MEDTRONIC PS MED INTRO ASM 14F -NJ*; MEDTRONIC PS MED INTRO ASM 15F. Recall # Z-1062-05
CODE
Catalog #, Lot Numbers: 333603--Lot #s 0060529076,0060542787, 0060551433, 0060552115, 0060553837, 0060562411, 0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806. 333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880. 333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808. 333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064, 0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074. 333614--0060521374, 0060551766, 0060702082. 610064--0060709374. 610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159. 610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688, 0060740847. 610106--0060702186. 610108--0060702192. 610109--0060713856. 610112--0060719604. 610113--0060723081. 610145--0060570243. 610146--0060560608. 610150--0060551068. 610151--0060707659, 0060710792. 610152--0060710794. 610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089. 610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191. 610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811, 0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955. 610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541. 610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992. 610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361, 0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403, 0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978. 610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504, 0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386. 610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071, 0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875. 610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910. 610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977, 0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524, 0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210. 611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193, 0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715, 0060709669. 612122--0060752209. 612124--0060755565, 0060759158. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911, 0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679, 0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491, 0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303, 0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782, 0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936, 0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484, 0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064. 614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276, 0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474, 0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423, 0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536, 0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069. 610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702, 0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711, 0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659. 7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417, 006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712, 0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624. 7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766. 7M3883--0060707663, 0060725281
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on May 27, 2005.
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN COMMERCE
1,105,700 cases
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries, Recall # Z-1063-05
CODE
Catalog # 400-01-290/291/292/295/296/297/ 498-28-048
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by e-mail on June 7, 2005. Firm initiated recall is ongoing.
REASON
Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
VOLUME OF PRODUCT IN COMMERCE
415 devices
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) PRIZM 2 DR, model 1861 Automatic Implantaable
Cardioveter Defibrillator, Contents have been
Sterilized with gaseous ethylene oxide,
Recall # Z-1064-05;
b) CONTAK Renewal 3 DS HE, model H177 CRT-D Cardiac
Resynchronization Therapy Defibrillator, Contents have
been sterilized with gaseous ethylene oxide,
Recall # Z-1065-05
CODE
a) 263958, 264039, 264055, 264058, 264059,
264060, 264064, 264066, 264069, 264070,
264112, 264117 and 264119;
b) 508822, 508827 and 508862
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by Sales Representatives on June 16, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Devices were manufactured with PEEK insulation material on the feed through wires and distributed prior to PMAS approval.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA, IL, MI, MO, OR, and PA

_______________________________
PRODUCT
Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor, Recall # Z-1067-05
CODE
Serial #s: A0746, A2434, A2435, A2437, A2438, A3363, A3364, A3365, A3366, A3370, A3371, A3659, A3660, A3661, A3662, A3664, A3665, A3666, A3668, A4409, A4410, A4411, A4574, A4575, A4577, A4578, A4579, A4580, A4581, A4582, A4583, A4584, A4586, A4587, A4588, A4589, A4590, A4591, A4593, A5205, A5559, A5560, A5561, A5565, A5566, A5568, A5569, A5570, A5763, A5764, A5765, A5766, A5767, A5787, A5788, A5789, A5790, A5791, A5792, A5793, A5794, A5941, A5943, A5944, A5946, A5948, A5951, A5952, A5956, A5959, A6073, A6074, A6075, A6078, A6079, A6081, A6429, A6430, A6431, A6432, A7374, A7376, A7378, A7380, A7381, A7382, B0115, B0117, B0185, B0187, B0188, B0189, B0190, B0191, B0192, B0193, B0194, B0195, B0196, B0197, B0198, B0199, B0200, B0201, B0204, B0205, B0208, B0209, B0210, B0211, B0212, B0240, B0241, B0242, B1815, B1817, B1818, B1819, B1861, B1862, B1865, B1866, B1868, B1869, B1870, B1871, B1908, B1909, B1910, B1912, B1914, B1915, B1916, B1917, B1976, B1977, B1978, B2107, B2109, B2110, B2113, B2114, B2115, B2116, B2117, B2118, B2119, B2122, B2124, B2125, B2126, B2128, B2130, B2131, B2133, B2134, B2135, B2142, B2145, B2146, B2147, B2148, B2150, B2404, B2700, B2701, B2702, B2704, B2705, B2708, B2709, B2710, B2712, B2713, B2714, B2716, B2717, B2718, B2721, B2722, B2723, B2724, B2725, B2735, B3171, B3174, T1518, T2419, T5712, T6686, T9728
RECALLING FIRM/MANUFACTURER
Power Surgical Solutions, Fort Wayne, TX, by letter on July 1, 2005. Firm initiated recall is ongoing.
REASON
Complaints of finger control component breaking off and falling into open surgical wound.
VOLUME OF PRODUCT IN COMMERCE
191 motors
DISTRIBUTION
Nationwide and Japan, Mexico, Netherlands, Canada, and Venezuela

_______________________________
PRODUCT
Sequoia Oxymatic electronic oxygen conservers, Models OM-302 and OM-311, Recall # Z-1068-05
CODE
Not provided
RECALLING FIRM/MANUFACTURER
Chad Therapeutics Inc, Chatsworth, CA, by letter on March 25, 2005. Firm initiated recall is ongoing.
REASON
?Shot size? below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.
VOLUME OF PRODUCT IN COMMERCE
150
DISTRIBUTION
Nationwide, Canada, Sweden, Norway, and Gibraltar

_______________________________
PRODUCT
a) ASY Brat 2 Procedure Set, for blood recovery &
autotransfusion, Catalog Number 007213100,
Recall # Z-1069-05;
b) ASY, Brat 2 Pack Procedure Set, Catalog Number:
007213102, Recall # Z-1070-05;
c) ASY Brat 2 Procedure Set, Catalog Number: 007214100,
Recall # Z-1071-05;
d) ASY, Brat Pack Procedure Set, Catalog Number: 007214102,
Recall # Z-1072-05;
e) ASY Brat 2 Procedure Set, Catalog Number: 007214900,
Recall # Z-1073-05;
f) ASY, Brat 2 Procedure Set, Castalog Number:007214901,
Recall # Z-1074-05
CODE
a) Lot Number: 0511600003, 0512300003, 0513000003,
0513700003, 0514400005;
b) Lot numbers 0511600004, 0512300004, 0513000005,
0513700004, 0514400006;
c) Lot Numbers 0511600001, 0511600002, 0512300001,
0512300002, 0513000002, 0513000001, 0513700001,
0513700002, 0514400002, 0514400003, 0514400004,
0515100185;
d) Lot numbers 0511600006, 0512300005, 0513000006,
0513700007, 0513700005, 0514400007, 0514400008,
0515100189;
e) Lot Number 0513700009;
f) Lot Numbers 0512300008, 0514400009
RECALLING FIRM/MANUFACTURER
Cobe Cardiovascular, Inc., Arvada, CO, by letter beginning June 22, 2005. Firm initiated recall is ongoing.
REASON
Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
6,294 units
DISTRIBUTION
Nationwide, Australia, Canada, Italy and Japan

_______________________________
PRODUCT
a) Product consists of a syringe used to inject
fluids during an angiographic procedure for
fluoroscopic imaging. Labeling is as follows:
Product Label ?***Argon Medical Device***10cc
Control Syringe FR/TR/FM w/ Reservoir SINGLE
USE ONLY***REF/REORDER NO. 093205***This
device is designed for the administration and
removal of fluids***Quantity: 25ea***NON-STERILE
*FURTHER PROCESSING REQUIRED***Eto (ethylene
oxide) Sterilization Recommended*** Carton Label
?***Argon Medical Device***10cc Control Syringe
FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/
REORDER NO. 093205***This device is designed
for the administration and removal of fluids***
Quantity: 250ea***NON-STERILE*FURTHER PROCESSING
REQUIRED***Eto (ethylene oxide) Sterilization
Recommended***, Recall # Z-1076-05;
b) Argon Medical Devices***CUSTOM MANIFOLD
KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port
Manifold, 500 PSI***1 ASY CDX3 Transducer***1
Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike
Line***1 10cc Control Syringe***1 M/F L/L PVC Line***
1 Stopcock Assy 4-way w/ MLL***1 Rotating Adapter,
M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio
Flushing Set***1 Zero Port Plug, Serrated***1 Monitor
Line Labels***STERILE EO***STERILIZED BY
EtO***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***
Carton Labeling: ***Argon Medical Devices***CUSTOM
MANIFOLD KIT***REF/REORDER NO. 194902A***Quantity: 10
ea***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE
STERILE EO***STERILIZED BY EtO***, Recall # Z-1077-05;
c) Product consists of a syringe used to inject fluids
during an angiographic procedure for fluoroscopic
imaging. Labeling is as follows: Product Label
***Argon Medical Device***REORDER NO./REF 193205***
10cc Control Syringe FR/TR/FM w/ Reservoir***This
device is designed for the administration and removal
of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT
RESTERILIZE***STERILE***EO***STERILIZED BY EtO***
Sterile Unless Opened or Damaged*** Carton Label
***Argon Medical Device***10cc Control Syringe
FR/TR/FM w/ Reservoir***This device is designed
for the administration and removal of fluids*
REF/REORDER NO. 193205***Quantity: 25 ea
*STERILE***EO***STERILIZED BY EtO***DISPOSABLE
***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile
Unless Opened or Damaged***, Recall # Z-1078-05;
c) Labeling is as follows: Product Labeling: ***Argon
Medical Devices***MANIFOLD KIT***SINGLE USE
ONLY***REF/REORDER NO. 094337***EtO STERILIZATION
RECOMMENDED***Caution: For manufacturing, processing
or repacking.*** Carton Labeling: ''***Argon Medical
Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/
REORDER NO. 094337***Quantity: 20 ea***NON-
STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene
oxide) Sterilization Recommended***,
Recall # Z-1079-05;
d) Labeling is as follows: Product Labeling:
***Argon Medical Devices***12cc Control
Syringe***FR/TR/RM w/ Reservoir***SINGLE USE
ONLY***REF/REORDER NO. 093209***This device is
designed for the administraion and removal of
fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER
PROCESSING REQUIRED***Eto (ethylene oxide)
Sterilization Recommended****** Carton Labeling:
***Argon Medical Devices***12cc Control
Syringe***FR/TR/RM w/ Reservoir***SINGLE USE
ONLY***REF/REORDER NO. 093209***This device is
designed for the administration and removal of
fluids.***Quantity: 250 ea***NON-STERILE*FURTHER
PROCESSING REQUIRED***EtO (ethylene oxide)
Sterilization Recommended***, Recall # Z-1080-05;
f) Labeling is as follows: Product labeling:
***Argon Medical Devices***RE-ORDER NO./REF
193248***12cc Control Syringe***ST/FR/TR/FM w/
Reservoir***This device is designed for the
administraion and removal of fluids.***
DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***
STERILE EO***STERILIZED BY EtO*** Carton
Labeling: ***Argon Medical Devices***12cc
Control Syringe***ST/FR/TR/FM W/ Reservoir***
This device is designed for the administration
and removal of fluids.***REF/REORDER NO.
193248***Quantity: 25 ea.***STERILE EO***
STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO
NOT RESTERILIZE***, Recall # Z-1081-05
CODE
a) Lot number: 99442547;
b) Lot number: 99444872;
c) Lot numbers: 99445447 and Lot number: 99445446;
d) Lot numbers: 99442306, Lot number: 99443999 and
Lot number: 99444179;
e) Lot number: 99440951, Lot number: 99443816 and
Lot number: 99443819;
f) Lot number: 99444008
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, by letters and telephone on June 27, 2005. Firm initiated recall is ongoing.
REASON
The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip.
VOLUME OF PRODUCT IN COMMERCE
4,879 units
DISTRIBUTION
Nationwide, Japan, Germany, and The Netherlands

_______________________________
PRODUCT
Orajel toddler Extra Gentle Yellow Manual Toothbrush, Model 7531, barcode # 3 10310 32362 2. Made in China -- The toothbrush is to be replaced every 3 months, Recall # Z-1082-05
CODE
This product does not have lot numbers assigned
RECALLING FIRM/MANUFACTURER
Recalling Firm: Del Pharmaceuticals, Inc., Farmingdale, NY, by letters on June 9, 2005 and July 21, 2005, and by press release on June 10, 2005.
Manufacturer: Yi Shing, Hong Kong, China. Firm initiated recall is ongoing.
REASON
Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
VOLUME OF PRODUCT IN COMMERCE
134,082 units domestically, and 1,578 units internally as free samples.
DISTRIBUTION
Nationwide and PR

_______________________________
PRODUCT
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box, product number RLA-142-3, Recall # Z-1083-05
CODE
Lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated July 11, 2005.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
There is a lack of assurance of sterility for parts of both lots of product.
VOLUME OF PRODUCT IN COMMERCE
62,000 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Puritan Bennett 840 Series Ventilator Power Supply, Model/Catalog Numbers: 4-076314-00; 4-076314-SP, Recall # Z-1085-05
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puritan Bennett, Pleasanton, CA, by letter on April 20, 2005.
Manufacturer: Puritain Bennett, Galway, Ireland. Firm initiated recall is ongoing.
REASON
Some of the screws from inside the power supply were loose or missing altogether. Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
VOLUME OF PRODUCT IN COMMERCE
309 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Baxter Sabraset 6060 Administration Set with
Pre-attached 250 mL Bag and Cassette, product
code 560500-250; Recall # Z-1086-05;
b) Baxter Sabraset 6060 Administration Set with
Pre-attached 100 mL Bag and Cassette, product
code 560500-100; Recall # Z-1087-05
CODE
a) Lots 417521, 418481, 418744
b) Lots 417519, 417520, 418482, 418483, 418745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated May 4, 2005.
Manufacturer: Avail Medical Products, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
VOLUME OF PRODUCT IN COMMERCE
20,745 units
DISTRIBUTION
Nationwide, Australia, Belgium, Canada and Japan

_______________________________
PRODUCT
a) Baxter 6060 Multi-Therapy Infusion Pump, product
code 2M9832, 606000-40, 606000-40L, 606000-40I;
Recall # Z-1088-05;
b) Baxter 6060E Epidural Infusion Pump, product code
2L9351 and 606000-40EL; Recall # Z-1089-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter on June 13, 2005.
Manufacturer: Baxter Healthcare, Corp., Singapore. Firm initiated recall is ongoing.
REASON
There is an overinfusion condition in the Intermittent mode where the pump may continue to deliver at the higher dose rate instead of switching to the lower keep open rate once the first dose is completed.
VOLUME OF PRODUCT IN COMMERCE
34,000 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 23 mm; Catalog number 8941423, Recall # Z-1090-05
CODE
Lot W05C5509
RECALLING FIRM/MANUFACTURER
Warsaw Orthopedic, Inc., Warsaw, IN, by letter, on May 27, 2005. Firm initiated recall is ongoing.
REASON
The product is labeled as sterile, but this lot was not sterilized.
VOLUME OF PRODUCT IN COMMERCE
140 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
a) ChemoSite Low Profile, Implantable Low Profile
Mini Catheter Venous Access System with printed
Polyurethane Catheter and 7 French Introducer Kit
Catalog Number: 120011, Recall # Z-1091-05;
b) ChemoSite Low Profile, Implantable Low Profile
Mini Catheter Venous Access System with printed
Polyurethane Catheter and 9 French Introducer Kit
Catalog Number: 120021, Recall # Z-1092-05;
c) ChemoSite Low Profile, Implantable Low Profile Mini
Catheter Venous Access System with 9 French
Introducer Kit with Silicone Catheter Catalog
Number: 120025, Recall # Z-1093-05;
d) ChemoSite Catheter Introducer Kit with 9 French
Peel-Away Sheath Catalog Number: 120039,
Recall # Z-1094-05;
e) ChemoSite Implantable venous access sytem with
printed Polyurethane Catheter and 9 French Introducer
Kit Catalog Number: 120045, Recall # Z-1095-05;
f) ChemoSite Implantable venous access sytem with
printed silicone Catheter and 9 French Introducer Kit
Catalog Number: 120066, Recall # 1096-05;
g) ChemoSIte Cathteter Introducer Kit with 7 French
Peel-Away Sheath Catalog Number: 120089,
Recall # Z-1097-05;
h) ChemoSite Implantable venous access sytem with
printed Polyurethane Catheter and 7 French Introducer
Kit Catalog Number: 120092, Recall # Z-1098-05
CODE
a) Lot Numbers: N4J395 N4K343;
b) Lot Numbers: N4G435 N4J328 N4K344 N5A181;
c) Lot numbers: N4J52 N4J329 N4J379;
d) Lot Numbers: N4G110 N4H201 N4K213 N4L82 N4M302
N4M522;
e) Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212
N4K218 N4L258 N4M213;
f) Lot Numbers: N4G293 N4H139 N4H439 N4J214 N4K53
N4K4245 N4L257 N4M214;
g) Lot Numbers: N4K141 N4L84;
h) Lot Numbers: N4K54 N4K431 N4L485 N4M93
RECALLING FIRM/MANUFACTURER
Recalling Firm: United States Surgical Corp., North Haven, CT, by letter dated June 30, 2005.
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
The peel away introducer sheath may have cracked hubs/handles and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN COMMERCE
8,473 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Baxter Interlink System Minivolume Extension Set,
product code 1C8290; 11", 0.86 mL Vol., with 2
injection sites and a male Luer Lock adapter;
Recall # Z-1099-05;
b) Baxter Interlink System Minivolume Extension Set,
product code 1C8462; 16?, 4.2 mL Vol., with 0.22
Micron Downstream High Pressure Extended Life
Filter, 2 injection sites and a male Luer Lock
adapter; Recall # Z-1100-05;
c) Baxter Interlink System Minivolume Extension Set,
product code 1C8483; 18?, 1.3 mL Vol., with 0.22
Micron Downstream Filter, 2 injection sites and a
male Luer Lock adapter; Recall # Z-1101-05;
d) Baxter Interlink System Y-Type Minivolume Extension
Set, product code 1C8645; 9", 0.8 mL Vol., with 2
injection sites and a male Luer Lock adapter;
Recall # Z-1102-05;
e) Baxter Interlink System Y-Type Minivolume Extension
Set, product code 1C8689; 6?, 0.33 mL Vol., with
male Luer Lock adapterRecall # Z-1103-05
CODE
a) Lots GR217836, GR219071, GR224220, GR225490,
GR227587;
b) Lots GR219444, GR223255, GR224659, GR227140;
c) Lots GR224238, GR227579;
d) Lots GR222042, GR224667, GR227173, GR228114;
e) Lot GD814186
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated July 6, 2005.
Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
VOLUME OF PRODUCT IN COMMERCE
25,160 sets
DISTRIBUTION
AZ, GA, IL, MI, OH, PA, SC, and TX

_______________________________
PRODUCT
Panorama Patient Monitoring Network Cardiac Arrhythmia Monitor, Recall # Z-1104-05
CODE
All units on the market
RECALLING FIRM
Datascope Corp, Mahwah, NJ, by letter on June 10, 2005. Firm initiated recall is ongoing.
REASON
Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
Nationwide, Belgium and Italy

_______________________________
PRODUCT
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters. Recall # Z-1105-05
CODE
All units with the following lot numbers being used by patients 13 years of age or younger: lots 4013674 through 4022628. The last affected lot expires in April 2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on July 15, 2005, by telephone and letters on July 18, 2005, and by press release on July 28, 2005.
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
VOLUME OF PRODUCT IN COMMERCE
Unknown -- 107 pediatric patients use the device
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Staarvisic II Sodium Hyaluronate, 0.8 mL, Recall # Z-1106-05
CODE
Lot B04118C, Exp. Date 12/31/2005
RECALLING FIRM
Recalling Firm: Staar Surgical Co. Inc., Monrovia, CA, by telephone, email and letter on July 18, 2005.
Manufacturer: Anika Therapeutics, Woburn, MA. Firm initiated recall is ongoing.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
16,464
DISTRIBUTION
Nationwide, Canada and PR

_______________________________
PRODUCT
Portable Oxygen Generator, Recall # Z-1368-05
CODE
All codes
RECALLING FIRM/MANUFACTURER
Inogen, Inc., Goleta, CA, by letter on August 1, 2005. Firm initiated recall is ongoing.
REASON
Firm plans to upgrade all units to correct situations that could lead to interruption in oxygen delivery.
VOLUME OF PRODUCT IN COMMERCE
920 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. Recall # Z-1370-05
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letters dated June 7, 2005.
Manufacturer: Sanmina SCI, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.
VOLUME OF PRODUCT IN COMMERCE
2,490 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

***CORRECTION***

In the July 20, 2005 Enforcement Report, Recall # Z-0974-05, Recalling Firm and Manufacturer is Theragenics Corporation, Buford, GA.

_______________________________
PRODUCT
Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32mm dia., neck length +0mm; Product 00-8018-032-02, Recall # Z-1066-05
CODE
Lot 60252787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated April 6, 2005.
Manufacturer: Zimmer Caribe, Inc., Mercedita, PR. Firm initiated recall is complete.
REASON
Mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ?stab incisions?. A non sterile, disposable, stainless steel blade. Reorder Number 371631, Recall # Z-1075-05
CODE
Lot Number 4322604
RECALLING FIRM
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters and telephone on April 9, 2005.
Manufacturer: Peg Bandages, Inc., Las Piedras, PR. Firm initiated recall is ongoing.
REASON
A small percentage of scalpels exhibited a ?double blade? condition.
VOLUME OF PRODUCT IN COMMERCE
48,000 units
DISTRIBUTION
IL, TX, UT, VA, TN, IN, and PR

_______________________________
PRODUCT
Roche Diagnostic Health Wear brand Professional System for weight management; Catalog # 04344456001, Recall # Z-1113-05
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 3, 2005.
Manufacturer: Body Media, Inc., Pittsburgh, PA. Firm initiated recall is ongoing.
REASON
Lack of adequate manufacturing controls.
VOLUME OF PRODUCT IN COMMERCE
1,005 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556, Recall # Z-1369-05
CODE
Not specified
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letters on May 5, 2005.
Manufacturer: I D S Co., Ltd., Bolden, England. Firm initiated recall is ongoing.
REASON
Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR AUGUST 17, 2005

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