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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November 10, 2004
04-45

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Jack's Fruit & Meat Market Almonds, natural raw, in random size packages. Recall # F-071-5.
CODE
Codes dates of August 21, 2003 through May 20, 2004.
RECALLING FIRM/MANUFACTURER
Jacks Markets, Essexville, MI, by press release issued on June 3, 2004. Firm initiated recall is complete.
REASON
Product was manufactured using almonds that were recalled by Paramount Foods due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
5,500 pounds.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Isosorbide Mononitrate, 30 mg. Extended release tablets, Rx only, 100
count bottles. NDC 59930-1502-1. Recall # D-053-5.
CODE
Lot 43480001; exp 08/2007.
RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Seymour, IN, by letter dated October 22, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: The label does not declare the presence of the following inactive ingredients: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose and talc.
VOLUME OF PRODUCT IN COMMERCE
39,322 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

CORRECTION

The Enforcement Report of October 6, 2004 (04-40) which reported Diltiazem Hydrochloride Extended Release Capsules, Recall # D-284-4 has been corrected, the Recalling Firm is Teva Pharmaceuticals, Sellersville, PA. The Reason -- Dissolution Failure (by manufacturer Biovail Corporation).

_______________________________
PRODUCT
a) TIAZAC Capsules (diltiazem hydrochloride), 180mg,
Extended Release, USP, 30 and 90 count bottles, Rx only.
Recall # D-050-5;
b) TIAZAC Capsules (diltiazem hydrochloride) 300mg, Extended
Release, USP, 30 and 90 count bottles, Rx only. Recall
# D-051-5.
CODE
a) 30 count bottles are identified with the following Lot
Numbers: 040178A, 040178B, 036401B & 035980A, Expiration
Date: FEB 28 07. 90 count bottles: 040178C, 036401A,
036401D & 039580B, Expiration Date: FEB 28 07;
b) 30 count bottles are identified with the following
Lot Numbers: 036457, 035057A, & 040072A, Expiration
Date: MAR 31 07. 90 count bottles: 035057B, 035976,
040072C & 040072B, Expiration Date: MAR 31 07.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services, Corp, Columbus, OH, by fax, e-mail and letter on October 4, 2004. Firm initiated recall is ongoing.
REASON
Dissolution failure (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE
13,320 bottles x 90 and/or 30 count repacked bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
A+D Original Ointment (Lanolin, 15.5% and Petrolatum, 53.4%), 4 oz tubes and 1 lb. jars. Recall # D-052-5.
CODE
Lot Number/NDC Number/ No Expiration Date: 4CL035, 11523-0096-2; 4G01A2, 11523-0096-3; 4G02A2, 11523-0096-3.
RECALLING FIRM/MANUFACTURER
Schering Plough Corp., Kenilworth, NJ, by letter on August 19, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: The Spanish text on the labeling incorrectly states 7 "horas" (hours) instead of 7 "dias" (days).
VOLUME OF PRODUCT IN COMMERCE
14,160 tubes and jars.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Whole Blood. Recall # B-0074-5;
b) Red Blood Cells. Recall # B-0075-5;
c) Red Blood Cells, Leukocytes Reduced. Recall # B-0076-5;
d) Platelets. Recall # B-0077-5;
e) Fresh Frozen Plasma. Recall # B-0078-5;
f) Recovered Plasma. Recall # B-0079-5.
CODE
a) Unit number: 31125-5240;
b) Unit numbers: 31124-8554, 31124-4362, 31125-4944, 31125-5241,
31125-5242, 31125-5980, 31125-6145, 31125-6873, 31125-7189,
31125-7666, 31125-7674, 31125-7675, 31125-7678, 31125-9026, 31125-9028, 31125-9057, 31125-9059, 31125-9089, 31125-9090, 31125-9092, 31125-9880, 31125-9884, 31125-9889, 31125-9891, 31125-9893, 31125-9895, 31125-9896, 31126-0110, 31126-0112, 31126-0230, 31126-0231, 31126-0233, 31126-0241, 31126-0242, 31126-0246, 31126-0248, 31126-0250, 31126-0251, 31126-0252, 31126-0266, 31126-0271, 31126-0272, 31126-0274, 31126-0277, 31126-0278, 31126-0279, 31126-0282, 31126-0283, 31126-0286, 31126-0288, 31126-0425, 31126-0428, 31126-0431, 31126-0435, 31126-0438, 31126-0457, 31126-0459, 31126-0461, 31126-0465, 31126-0470, 31126-0515, 31126-0518, 31126-0950, 31126-1188, 31126-1190, 31126-1194, 31126-1196, 31126-1425, 31126-1427, 31126-1428, 31126-1534, 31126-1537, 31126-1538, 31126-1652, 31126-1669, 31126-1704, 31126-1707, 31126-1711, 31126-1713, 31126-1714, 31126-1719, 31126-1721, 31126-1723, 31126-1727, 31126-1731, 31126-1733, 31126-1736, 31126-1973, 31126-1974, 31126-1992, 31126-1996, 31126-1998, 31126-2000, 31126-2004, 31126-2180, 31126-2223, 31126-2225, 31126-2227, 31126-2362, 31126-2363, 31126-2364, 31126-2366, 31126-2370, 31126-2374, 31126-2375, 31126-2376, 31126-2602, 31126-2606, 31126-2637, 31126-2683, 31126-2711, 31126-3024, 31126-3028, 31126-3037, 31126-3060, 31126-3071, 31126-3074, 31126-3075, 31126-3076, 31126-3078, 31126-3079, 31126-3080, 31126-3135, 31126-3138, 31126-3139, 31126-3162, 31126-3202, 31126-3204, 31126-3206, 31126-3210, 31126-3211, 31126-3214, 31126-3217, 31126-3219, 31126-3383, 31126-3385, 31126-3387, 31126-3620, 31126-3625, 31126-3633, 31126-3636, 31126-3638, 31126-3641, 31126-3644, 31126-3654, 31126-3695, 31126-3696, 31126-3697, 31126-3698, 31126-3700, 31126-3701, 31126-3702, 31126-3705, 31126-3707, 31126-3708, 31126-3709, 31126-3710, 31126-4128, 31126-4135, 31126-4136, 31126-4140, 31126-4556, 31126-4557, 31126-4558, 31126-4559, 31126-4563, 31126-4564, 31126-4567, 31126-4586, 31126-4588, 31126-4590, 31126-4593, 31126-4595, 31126-4596, 31126-4597, 31126-4598, 31126-4600, 31126-4695, 31126-4868, 31126-4875, 31126-4881, 31126-4917, 31126-4924, 31126-5080, 31126-5601, 31126-5604, 31126-5605, 31126-5607, 31126-5608, 31126-5609, 31126-5612, 31126-5613, 31126-6685, 31126-6689, 31126-6693, 31126-6697, 31126-6700, 31126-6704, 31126-6709, 31126-6712, 31126-6713, 31126-6725, 31126-7136. 31126-7507, 31126-7509, 31126-7511, 31126-7513, 31126-7515, 31126-7518, 31126-7521, 31126-7524, 31126-7527, 31126-7528, 31126-7531, 31126-7534, 31126-7536, 31126-7537, 31126-7540, 31126-7901, 31126-7903, 31126-7904, 31126-7908, 31126-7909, 31126-7923, 31126-8253, 31126-8254, 31126-8255, 31126-8257, 31126-8258, 31126-8259, 31126-8260, 31126-8273, 31126-8274, 31126-8275, 31126-8276, 31126-8277, 31126-8278, 31126-8297, 31126-8300, 31126-8301, 31126-8344, 31126-8345, 31126-8346, 31126-8352, 31126-8364, 31126-8372, 31126-8373, 31126-8374, 31126-8376, 31126-8377, 31126-8552, 31126-8553, 31126-8562, 31126-8564, 31126-8566, 31126-8567, 31126-8568, 31126-8569, 31126-8571, 31126-8572, 31126-8573, 31126-8774, 31126-8784, 31126-8791, 31126-9124, 31126-9126, 31126-9127, 31126-9234, 31126-9236, 31126-9241, 31126-9242, 31126-9244, 31126-9245, 31126-9248, 31126-9249, 31126-9519, 31126-9602, 31126-9605, 31126-9617, 31126-9618, 31126-9619, 31126-9623, 31126-9628, 31126-9633, 31126-9635, 31126-9636, 31126-9656, 31126-9661, 31126-9663, 31126-9667, 31126-9669, 31126-9681, 31126-9689, 31126-9748, 31126-9751, 31126-9752, 31126-9753, 31126-9754, 31126-9758, 31126-9759, 31126-9761, 31127-0144, 31127-0154, 31127-0155, 31127-0166-01, 31127-0166-02, 31127-0166-03, 31127-0279, 31127-0282, 31127-0318, 31127-0327, 31127-0328, 31127-0331, 31127-0332, 31127-0715, 31127-0717, 31127-0718, 31127-0720, 31127-0721, 31127-0722, 31127-0723, 31127-0724, 31127-0725, 31127-0727, 31127-0728, 31127-0729, 31127-0730, 31127-0731, 31127-0733, 31127-0734, 31127-0736, 31127-1062, 31127-1064, 31124-1065, 31127-1068, 31127-1070, 31127-1074, 31127-1075, 31127-1086, 31127-1102, 31127-1265, 31127-1268, 31127-1270, 31127-1275, 31127-1279, 31127-1280, 31127-1284, 31127-1288, 31127-1289, 31127-1825, 31127-1828, 31127-1829, 31127-1831, 31127-1833, 31127-1835, 31127-1837, 31127-1838, 31127-1843, 31127-1846, 31127-1847, 31127-1848, 31127-1899, 31127-1900, 31127-1906, 31127-1909, 31127-1910, 31127-1913, 31127-1917, 31127-1918, 31127-1921, 31127-1922, 31127-1926, 31127-1928, 31127-1930, 31127-2175, 31127-2177, 31127-2178, 31127-2181, 31127-2186, 31127-2189, 31127-2190, 31127-2194, 31127-2195, 31127-2197, 31127-2198, 31127-2341, 31127-2342, 31127-2344, 31127-2346, 31127-2347, 31127-2350, 31127-2354, 31127-2499, 31127-2529, 31127-2666, 31127-2814, 31127-2841, 31127-2846, 31127-2850, 31127-3003, 31127-3006, 31127-3011, 31127-3013, 31127-3023, 31127-3024, 31127-3025, 31127-3026, 31127-3104, 31127-3105, 31127-3107, 31127-3109, 31127-3110, 31127-3112, 31127-3116, 31127-3117, 31127-3118, 31127-3119, 31127-3122, 31127-3124, 31127-3125, 31127-3490, 31127-3491, 31127-3492, 31127-3493, 31127-3494, 31127-3495, 31127-3497, 31127-3498, 31127-3499, 31127-3500, 31127-3502, 31127-3504, 31127-3509, 31127-3511, 31127-3514, 31127-4002, 31127-4003, 31127-4005, 31127-4007, 31127-4008, 31127-4009, 31127-4010, 31127-4012, 31127-4014, 31127-4015, 31127-4017, 31127-4018, 31127-4227, 31127-4230, 31127-4232, 31127-4233, 31127-4237, 31127-4238, 31127-4240, 31127-4241, 31127-4507, 31127-4507, 31127-4510, 31127-4513, 31127-4514, 31127-4515, 31127-4516, 31127-4517, 31127-4519, 31127-4524, 31127-4530, 31127-4534, 31127-4535, 31127-4539, 31127-4542, 31127-4543, 31127-4545, 31127-4564, 31127-4565, 31127-4568, 31127-4570, 31127-4571, 31127-4573, 31127-4575, 31127-4576, 31127-4580, 31127-4686, 31127-4695, 31127-4958, 31127-4959, 31127-4960, 31127-4961, 31127-4962, 31127-4963, 31127-4965, 31127-4966, 31127-4967, 31127-4968, 31127-4969, 31127-4970, 31127-4971, 31127-4973, 31127-4974, 31127-4975, 31127-4976, 31127-4978, 31127-4979, 31127-5226, 31127-5227, 31127-5229, 31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235, 31127-5236, 31127-5237, 31127-5238, 31127-5239, 31127-5240, 31127-5241, 31127-5242, 31127-5243, 31127-5245, 31127-5247, 31127-5249, 31127-5251, 31127-5252, 31127-5264, 31127-5353, 31127-5441, 31127-5442, 31127-5454, 31127-5458, 31127-5461, 31127-5863, 31127-5876, 31127-5877, 31127-5879, 31127-5884, 31127-5886, 31127-5896, 31127-5900, 31127-5901, 31127-5903, 31127-5929, 31127-5930, 31127-5931, 31127-5932, 31127-5938, 31127-5941, 31127-5944, 31127-5945, 31127-5946, 31127-5948, 31127-5951, 31127-5952, 31127-5957, 31127-5958, 31127-5959, 31127-6056, 31127-6057, 31127-6058, 31127-6060, 31127-6061, 31127-6063, 31127-6066, 31127-6067, 31127-6068, 31127-6070, 31127-6072, 31127-6073, 31127-6074, 31127-6076, 31127-6785, 31127-6790, 31127-6791, 31127-6792, 31127-6796, 31127-7029, 31127-7042, 31127-7043, 31127-7044, 31127-7085, 31127-7096, 31127-7130, 31127-7131, 31127-7132, 31127-7133, 31127-7136, 31127-7137, 31127-7138, 31127-7139, 31127-7141, 31127-7142, 31127-7145, 31127-7146, 31127-7149, 31127-7150, 31127-7152, 31127-7155, 31127-7156, 31127-7452, 31127-7550, 31127-7551, 31127-7552, 31127-7553, 31127-7554, 31127-7556, 31127-7557, 31127-7560, 31127-7561, 31127-7563, 31127-7564, 31127-7565, 31127-7568, 31127-7569, 31127-7570, 31127-7571, 31127-7572, 31127-7578, 31127-7579, 31127-7581, 31127-7584, 31127-7585, 31127-7586, 31127-7591, 31127-7603, 31127-7604, 31127-7629, 31127-7801, 31127-7802, 31127-7805, 31127-7807, 31127-7808, 31127-7809, 31127-7810, 31127-7812, 31127-7814, 31127-7815, 31127-7816, 31127-7818, 31127-7819, 31127-7820, 31127-7821, 31127-7823, 31127-7824, 31127-7825, 31127-7826, 31127-7828, 31127-7829, 31127-7936, 31127-7941, 31127-7943, 31127-7944, 31127-7945, 31127-7946, 31127-7947, 31127-7948, 31127-7949, 31127-7950, 31127-7951, 31127-7952, 31127-8036, 31127-8037, 31127-8038, 31127-8039, 31127-8040, 31127-8041, 31127-8042, 31127-8044, 31127-8111, 31127-8224, 31127-8225, 31127-8226, 31127-8231, 31127-8232, 31127-8233, 31127-8234, 31127-8235, 31127-8236, 31127-8239, 31127-8240, 31127-8242, 31127-8243, 31127-8244, 31127-8246, 31127-8247, 31127-8248, 31127-8249, 31127-8250, 31127-8253, 31127-8276, 31127-8278, 31127-8279, 31127-8281, 31127-8282, 31127-8283, 31127-8287, 31127-8294, 31127-8296, 31127-8298, 31127-8300, 31127-8301, 31127-8305, 31127-8311, 31127-8312, 31127-8314, 31127-8315, 31127-8319, 31127-8320, 31127-8323, 31127-8453, 31127-8456, 31127-8462, 31127-8464, 31127-8465, 31127-8466, 31127-8467, 31127-8473, 31127-8476, 31127-8477, 31127-8479, 31127-8482, 31127-8484, 31127-8490, 31127-8492, 31127-8495, 31127-8496, 31127-8499, 31127-8502, 31127-8503, 31127-8505, 31127-8506, 31127-8507, 31127-8515, 31127-8516, 31127-9202, 31127-9203, 31127-9205, 31127-9207, 31127-9209, 31127-9211, 31127-9214, 31127-9502, 31127-9530-01, 31127-9530-02, 31127-9530-03, 31127-9547, 31127-9554, 31127-9561, 31127-9565, 31127-9566, 31127-9567, 31127-9572, 31126-3655, 31126-4328, 31126-4686, 31126-9683, 31127-5225;
c) Unit numbers: 31125-4161, 31125-4950, 31125-5978, 31125-
7673, 31125-9887, 31126-0386, 31126-0463, 31126-0517, 31126- 1186, 31126-1527, 31126-1532, 31126-1536, 31126-1542,
31126-1677, 31126-1680, 31126-1718, 31126-2094, 31126-2095, 31126-2179, 31126-2211, 31126-2639, 31126-2641, 31126-2643, 31126-2645, 31126-2648, 3126-2649, 31126-2693, 31126-2719, 31126-2720, 31126-3015, 31126-3030, 31126-3116, 31126-3199, 31126-3381, 31126-3384, 31126-3647, 31126-3658, 31126-3659, 31126-3694, 31126-3699, 31126-3704, 31126-4161, 31126-4394, 31126-4397, 31126-4560, 31126-4561, 31126-4569, 31126-4589, 31126-4591, 31126-4592, 31126-4594, 31126-4607, 31126-4688, 31126-4689, 31126-4690, 31126-4691, 31126-4693, 31126-5078, 31126-5079, 31126-5602, 31126-5603, 31126-5606, 31126-5814, 31126-5815, 31126-5839, 31126-5840, 31126-5846, 31126-5848, 31126-6604, 31126-6687, 31126-6692, 31126-6699, 31126-6710, 31126-6715, 31126-6719, 31126-9125, 31126-9129, 31126-9136, 31126-9137, 31127-0272, 31127-0275, 31127-0278, 31127-0315, 31127-0326, 31127-1099, 31127-2458, 31127-2459, 31127-2460, 31127-2462, 31127-2466, 31127-2469, 31127-2473, 31127-2668, 31127-2675, 31127-2680, 31127-2683, 31127-2684, 31127-2685, 31127-2687, 31127-3506, 31127-3510, 31127-5012, 31127-5540, 31127-5541, 31127-5546, 31127-5547, 31127-5548, 31127-5549, 31127-5833, 31127-5842, 31127-5846, 31127-5850, 31127-5860, 31127-5862, 31127-7140, 31127-7144, 31127-7153, 31127-8561, 31127-8562, 31127-8565, 31127-8567, 31127-8574, 31127-8578, 31127-9541;
d) Unit numbers: 31125-4944, 31126-0230;
e) Unit numbers: 31125-6873, 31125-7666, 31125-7673, 31125-7674,
31125-7678, 31125-1677, 31126-1680, 31126-1704, 31126-1707, 31126-1711, 31126-1713, 31126-1714, 31126-1718, 31126-1719, 31126-1721, 31126-3620, 31126-3625, 31126-3633, 31126-3636, 31126-3638, 31126-3641, 31126-3644, 31126-3647, 31126-3655, 31126-3697, 31126-4161, 31126-6685, 31126-6687, 31126-6689, 31126-6692, 31126-6693, 31126-6710, 31126-6712, 31126-6713, 31126-6715, 31126-6719, 31126-8345, 31126-8364, 31126-8372, 31126-8373, 31126-8374, 31126-8377, 31126-8562, 31126-8564, 31126-9236, 31127-0155, 31127-0332, 31127-2197, 31127-5225, 31127-5226, 31127-5227, 31127-5228, 31127-5229, 31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235, 31127-5236, 31127-5237, 31127-5238, 31127-5239, 31127-5240, 31127-5242, 31127-5243, 31127-5245, 31127-5247, 31127-7042, 31127-7043, 31127-7044, 31127-7130, 31127-7131, 31127-7133, 31127-7136, 31127-7137, 31127-7138, 31127-7139, 31127-7140, 31127-7141, 31127-7143, 31127-7144, 31127-7150, 31127-7152, 31127-7554, 31127-7556, 31127-7564, 31127-7569, 31127-7585, 31127-7807, 31127-7809, 31127-7810, 31127-7812, 31127-8036, 31127-8037, 31127-8477, 31127-9205, 31127-9207, 31127-9211;
f) Unit numbers: 31125-4161, 31125-4362, 31125-4944, 31125-
4950, 31125-5242, 31125-5978, 31125-5980, 31125-6145, 31125- 7189, 31125-9026, 31125-9028, 31125-9057, 31125-9059, 31125-9089, 31125-9090, 31125-9092, 31125-9880, 31125-9884, 31125-9887, 31125-9889, 31125-9891, 31125-9893, 31125-9895, 31125-9896, 31126-0110, 31126-0112, 31126-0230, 31126-0231, 31126-0233, 31126-0241, 31126-0242, 31126-0246, 31126-0248, 31126-0250, 31126-0251, 31126-0252, 31126-0266, 31126-0271, 31126-0272, 31126-0274, 31126-0277, 31126-0278, 31126-0279, 31126-0282, 31126-0283, 31126-0286, 31126-0288, 31126-0386, 31126-0425, 31126-0428, 31126-0431, 31126-0435, 31126-0438, 31126-0457, 31126-0459, 31126-0461, 31126-0463, 31126-0465, 31126-0470, 31126-0515, 31126-0517, 31126-0518, 31126-0950, 31126-1186, 31126-1188, 31126-1190, 31126-1194, 31126-1196, 31126-1427, 31126-1428, 31126-1527, 31126-1532, 31126-1534, 31126-1536, 31126-1537, 31126-1538, 31126-1542, 31126-1652, 31126-1669, 31126-1723, 31126-1727, 31126-1731, 31126-1733, 31126-1736, 31126-1973, 31126-1974, 31126-1992, 31126-1996, 31126-1998, 31126-2000, 31126-2004, 31126-2094, 31126-2095, 31126-2179, 31126-2180, 31126-2223, 31126-2225, 31126-2227, 31126-2362, 31126-2363, 31126-2364, 31126-2366, 31126-2370, 31126-2374, 31126-2375, 31126-2376, 31126-2602, 31126-2606, 31126-2637, 31126-2639, 31126-2641, 31126-2643, 31126-2645, 31126-2648, 31126-2649, 31126-2683, 31126-2693, 31126-2711, 31126-2719, 31126-2720, 31126-3015, 31126-3024, 31126-3028, 31126-3030, 31126-3037, 31126-3060, 31126-3071, 31126-3074, 31126-3075, 31126-3076, 31126-3078, 31126-3079, 31126-3080, 31126-3116, 31126-3135, 31126-3138, 31126-3139, 31126-3162, 31126-3199, 31126-3202, 31126-3204, 31126-3206, 31126-3210, 31126-3211, 31126-3214, 31126-3217, 31126-3219, 31126-3381, 31126-3383, 31126-3384, 31126-3385, 31126-3387, 31126-3654, 31126-3658, 31126-3659, 31126-3694, 31126-3695, 31126-3696, 31126-3698, 31126-3699, 31126-3700, 31126-3701, 31126-3702, 31126-3704, 31126-3705, 31126-3707, 31126-3708, 31126-3709, 31126-3710, 31126-4124, 31126-4128, 31126-4135, 31126-4136, 31126-4140, 31126-4328, 31126-4394, 31126-4397, 31126-4556, 31126-4557, 31126-4558, 31126-4559, 31126-4560, 31126-4561, 31126-4563, 31126-4564, 31126-4567, 31126-4569, 31126-4586, 31126-4588, 31126-4589, 31126-4590, 31126-4591, 31126-4592, 31126-4593, 31126-4594, 31126-4595, 31126-4596, 31126-4597, 31126-4598, 31126-4600, 31126-4607, 31126-4686, 31126-4688, 31126-4689, 31126-4690, 31126-4691, 31126-4693, 31126-4868, 31126-4875, 31126-4881, 31126-4917, 31126-4924, 31126-5078, 31126-5079, 31126-5080, 31126-5601, 31126-5602, 31126-5603, 31126-5604, 31126-5606, 31126-5607, 31126-5608, 31126-5609, 31126-5612, 31126-5613, 31126-5814, 31126-5815, 31126-5839, 31126-5840, 31126-5846, 31126-5848, 31126-6604, 31126-6697, 31126-6699, 31126-6700, 31126-6704, 31126-6709, 31126-6725, 31126-7136, 31126-7507, 31126-7509, 31126-7511, 31126-7513, 31126-7515, 31126-7518, 31126-7521, 31126-7524, 31126-7527, 31126-7528, 31126-7531, 31126-7534, 31126-7536, 31126-7537, 31126-7540, 31126-7901, 31126-7903, 31126-7904, 31126-7908, 31126-7909, 31126-7923, 31126-8253, 31126-8254, 31126-8255, 31126-8257, 31126-8258, 31126-8259, 31126-8260, 31126-8273, 31126-8274, 31126-8275, 31126-8276, 31126-8277, 31126-8278, 31126-8297, 31126-8301, 31126-8344, 31126-8346, 31126-8352, 31126-8376, 31126-8552, 31126-8553, 31126-8566, 31126-8567, 31126-8568, 31126-8569, 31126-8571, 31126-8572, 31126-8573, 31126-9234, 31126-9241, 31126-9242, 31126-9245, 31126-9248, 31126-9249, 31126-9635, 31127-0144, 31127-0154, 31127-0166, 31127-0272, 31127-0275, 31127-0278, 31127-0318, 31127-0326, 31127-0715, 31127-0717, 31127-0718, 31127-0720, 31127-0721, 31127-0722, 31127-0723, 31127-0724, 31127-0725, 31127-0727, 31127-0728, 31127-0729, 31127-0730, 31127-0731, 31127-0733, 31127-0734, 31127-0736, 31127-1062, 31127-1064, 31127-1065, 31127-1068, 31127-1070, 31127-1074, 31127-1075, 31127-1086, 31127-1099, 31127-1102, 31127-1265, 31127-1268, 31127-1270, 31127-1275, 31127-1279, 31127-1280, 31127-1284, 31127-1288, 31127-1289, 31127-1825, 31127-1828, 31127-1829, 31127-1831, 31127-1833, 31127-1835, 31127-1837, 31127-1838, 31127-1843, 31127-1846, 31127-1847, 31127-1848, 31125-6873, 31125-7666, 31125-7673, 31125-7674, 31125-7678, 31125-1677, 31126-1680, 31126-1704, 31126-1707, 31126-1711, 31126-1713, 31126-1714, 31126-1718, 31126-1719, 31126-1721, 31126-3620, 31126-3625, 31126-3633, 31126-3636, 31126-3638, 31126-3641, 31126-3644, 31126-3647, 31126-3655, 31126-3697, 31126-4161, 31126-6685, 31126-6687, 31126-6689, 31126-6692, 31126-6693, 31126-6710, 31126-6712, 31126-6713, 31126-6715, 31126-6719, 31126-8345, 31126-8364, 31126-8372, 31126-8373, 31126-8374, 31126-8377, 31126-8562, 31126-8564, 31126-9236, 31127-0155, 31127-0332, 31127-2197, 31127-5225, 31127-5226, 31127-5227, 31127-5228, 31127-5229, 31127-5230, 31127-5231, 31127-5232, 31127-5233, 31127-5235, 31127-5236, 31127-5237, 31127-5238, 31127-5239, 31127-5240, 31127-5242, 31127-5243, 31127-5245, 31127-5247, 31127-7042, 31127-7043, 31127-7044, 31127-7130, 31127-7131, 31127-7133, 31127-7136, 31127-7137, 31127-7138, 31127-7139, 31127-7140, 31127-7141, 31127-7143, 31127-7144, 31127-7150, 31127-7152, 31127-7554, 31127-7556, 31127-7564, 31127-7569, 31127-7585, 31127-7807, 31127-7809, 31127-7810, 31127-7812, 31127-8036, 31127-8037, 31127-8477, 31127-9205, 31127-9207, 31127-9211.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 9, 2000, and by letter, dated December 20, 2000.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,327 units.
DISTRIBUTION
AL, CA, MS, TN, TX, VA, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-0129-5.
CODE
Units 71Z805952, 71Z814752.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL, by facsimile on May 18, 2004.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0130-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0131-5.
CODE
a) Unit 71M208421;
b) Units 71Z746216, 71L351184.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL, by facsimile on May 6, 2004.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL.

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0140-5.
CODE
Unit number 71W152771.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc. Gainesville, FL, by telephone on October 20, 2003.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood product with an insufficient plasma volume was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0142-5.
CODE
Unit numbers 38P81644 and 38P82244.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on October 14, 2003, and by letter on October 24, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0143-5.
CODE
Unit number 18235-3908.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on September 23, 2004.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is ongoing.
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
WY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0144-5.
CODE
Unit numbers 6010206699, 6010206273, 6010206038, 6010204919, 6010201829, and 6010200249.
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, San Antonio, TX, by letters on May 24 and 28, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of post donation information from the donor related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
Korea.

___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-0145-5.
CODE
Unit 21KP46496.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on April 17, 2003, and by letter dated April 18, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0146-5.
CODE
Unit 7404324.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile on August 5, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0151-5.
CODE
Unit GE70804.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 23, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0152-5.
CODE
Unit 231494455.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on October 7, 2003 or by letter dated November 7, 2003.
Manufacturing Firm: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY and Switzerland.

_______________________________
PRODUCT
Platelets. Recall # B-0157-5.
CODE
Unit number 2095359.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on July 27, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets. Recall # B-0158-5.
CODE
Unit number 2096266.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on June 16, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0159-5.
CODE
Unit number 1222743 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on April 15, 2004. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Human Tissue for Transplantation of the following types:
a) Various musculoskeletal tissues (e.g., fascia, bone,
and tendon);
b) Various cardiovascular tissues (e.g., saphenous vein
and femoral vein). Recall # B-0160-5.
CODE
Donor number 11099275.
RECALLING FIRM/MANUFACTURER
Mid-American Transplant Service, Olivette, MO, by electronic mail on December 27 and 28, 2001. Firm initiated recall is complete.
REASON
Human Tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO and GA.

_______________________________
PRODUCT
Human Corneas. Recall # B-0164-5.
CODE
Units 041342100 and 041342200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by letter dated October 12, 2004. Firm initiated recall is ongoing.
REASON
Human tissues, which were collected from a donor who was not adequately evaluated for suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO, and OH.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0166-5;
b) Recovered Plasma. Recall # B-0167-5.
CODE
a) and b) Unit 171997240.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letters dated March 12 and May 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0169-5;
b) Recovered Plasma. Recall # B-0170-5.
CODE
a) and b) Unit number 2028845.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on August 6, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY and NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0171-5;
b) Platelets. Recall # B-0172-5;
c) Fresh Frozen Plasma. Recall # B-0173-5.
CODE
a), b), and c) Unit number 2081820.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on July 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to medication with the drug Tegison, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0179-5.
CODE
Unit numbers: F-41378-011, F-41035-011, F-40321-011, F-40010-011, F-39242-011, F-38952-011, F-38231-011, and F-37848-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corp, Los Angeles, CA, by letter dated August 26, 2003.
Manufacturing Firm: Alpha Therapeutic Corp, Portland, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Spain.

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0180-5.
CODE
Unit 231499645.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by facsimile on November 6, 2003, or by letter dated December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0182-5.
CODE
Units 21FM93661 and 21FM85188.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on September 12, 2003, and by letter dated September 15, 2003. 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
OR.

_______________________________
PRODUCT
Source Plasma. Recall # B-0183-5.
CODE
Units G79835070, G80076070, G81405070, G81891070, G82054070, G82610070, G83079070, G83218070, G83642070, G83929070, G84308070, G84519070, G84888070, G85152070, G85602070, G85804070, G86346070, G87140070, G87522070, G87723070, G88208070, G88411070, G88784070, G88966070, G89380070, G89579070, G89955070, G90187070, G90559070, G90775070, G91129070, G91316070, G91672070, G91866070, G92287070, G92627070, G92934070, G93279070, G93569070, G93916070, G94191070, G94527070, G94892070, G95369070, G95615070, G95970070, G96279070, G96573070, G97012070, G07409070, G07578070, G08026070, G08323070, G08700070, G11727070, G12022070, and G12360070.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Vancouver, WA, by facsimile on July 12, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who received a tattoo within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units
DISTRIBUTION
NC, Switzerland, and Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-0186-5.
CODE
Units G77175001, G77343001, G78075001, G78924001, G79246001, G79522001, G83555001, G84157001, F00486001, F00656001, F01484001, F01824001, F03552001, F03842001, F04322001, F04794001, F05229001, and F05448001.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR, by facsimile on December 30 & 31, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NC, and Spain.

_______________________________
PRODUCT
Platelets. Recall # B-0193-5.
CODE
Unit M78793.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on August 25, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0194-5.
CODE
Unit S78529
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by telephone on August 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced but labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets. Recall # B-0195-5.
CODE
Unit M78982.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on September 10, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets. Recall # B-0196-5.
CODE
Unit N09731.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on September 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0197-5.
b) Platelets. Recall # B-0198-5.
CODE
a) and b) Units K40576 and L52966.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on August 27, 2004. 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
4 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0199-5.
CODE
Unit 224320491.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on July 31, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0201-5.
CODE
Unit 150233677.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letter dated November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0202-5.
CODE
Units 150225270 (2 units), 150220153 (2 units), 150220147 (2 units), 150220166 (2 units), 150212735 (2 units), 150212719 (2 units), 150220741 (2 units), 150220162 (2 units), 150220797, and 150225368.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on August 21 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0101-5.
CODE
Unit number: KE92184.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by letter dated October 8, 2002. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0119-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0120-5.
CODE
a) Unit 71J582870;
b) Units 71J40794X, 71L496281, 71L496293.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on May 25, 2004.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AL.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0127-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-
0128-5.
CODE
a) Units 71L61175X, 71L476927, 71J073111;
b) Units 71L52260X, 71W621660, 71W621715.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by telephone on April 21, 2004 and by facsimile on May 12, 2004.
Manufacturing Firm: LifeSouth Community Blood Centers, Inc., Montgomery Region, Montgomery, AL. Firm initiated recall is complete.
REASON
Blood products, incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0141-5.
CODE
Unit number 71J232962.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on September 22, 2003.
Manufacturer: LifeSouth Community Blood Centers, Birmingham Region, Birmingham, AL. Firm initiated recall is complete.
REASON
Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0153-5.
CODE
Unit 231494455.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on October 7, 2003 or by letter dated November 7, 2003.
Manufacturing Firm: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY and Switzerland.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0165-5.
CODE
Units 172016433 and 172017798.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letter dated November 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0168-5.
CODE
Units 172012277, 172012278, 172013624, 172013627 and 172013628.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone and letter dated June 3, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0174-5.
CODE
Unit number 22KL07639 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on April 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

___________________________________
PRODUCT
Recovered Plasma. Recall # B-0181-5.
CODE
Unit 231499645.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by facsimile on November 6, 2003, or by letter dated December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-0184-5.
CODE
Unit 498232.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, TX, by facsimile on October 17, 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
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0185-5.
CODE
Unit 498368.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, TX, by facsimile on October 3, 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
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0192-5.
CODE
Unit numbers: 15021-6648, 15021-6726, 15021-3766, 15021-6508, 15021-3799, 15021-6772, 15021-7341, 15021-7320, and 15021-7538.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on October 2, 2003. Firm initiated recall is complete.
REASON
Blood products, which was shipped without documenting temperatures of shipping containers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0200-5.
CODE
Unit 150226353.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on August 20, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not stored at acceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) X-ray system GE OEC Series 7600. Recall # Z-1067-04;
b) Compact Series 7600. Recall # Z-1068-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Salt Lake City, UT, by firm representative visit implementing Field Modification Instruction 15019 beginning on October 14, 2004. Firm initiated recall is ongoing.
REASON
The x-ray product failed to comply with the Federal x-ray product performance standard, whereby unintended x-rays are emitted upon boot-up if the footswitch is engaged.
VOLUME OF PRODUCT IN COMMERCE
323 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
MUX-100H Mobile Radiography System. Recall # Z-1486-04
CODE
All MUX-100H Mobile Radiography Systems.
RECALLING FIRM/MANUFACTURER
Shimadzu Corp., Torrance, CA, by service representative visit beginning on October 22, 2004. Firm initiated recall is ongoing.
REASON
The spacer hardware does not maintain the proper minimum distance allowed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 219 units.
DISTRIBUTION
Nationwide.

___________________________________
PRODUCT
a) 8 ml Inject8 Coronary Control Syringe, sterile.
Product Number CCS880. Recall # Z-0048-05;
b) 10 ml Inject 10 Palm Pad, sterile, Product Number CCXB010/A.
Recall # Z-0049-05;
c) Convenience Kits containing Inject8 or Inject10 syringes.
Recall # Z-0050-05.
CODE
a) Lot numbers A333586, A337519, A341381, A337458, A341399.
b) Lot Number A337459.
c) Part No. K07-00116AP, Lot Nos A340949, A346191.
Part No. K09-00302FP, Lot # A340485, A341488
Part No. K09-00579CP, Lot # A339214, A345673
Part No. K09-00585LP, Lot # A338201, A344694
Part No. K09-00759DP, Lot #A342359, A345674, A347263.
Part No. K09-00946MP, Lot # A341491
Part No. K09-00970K, Lot # A337245
Part No. K09-01574G, Lot # A343825
Part No. K09-01673H, Lot # A342676
Part No. K09-01908AP, Lot # A338729, A344187, A344382.
Part No. K09-02104HP, Lot # A337839, A346138
Part No. K09-02249H, Lot # A343819
Part No. K09-02249HP, Lot # A339688
Part No. K09-02334K, Lot # A345405
Part No. K09-02353G, Lot # A342675
Part No. K09-03242C, Lot # A342165
Part No. K09-03528D, Lot # A341710
Part No. K09-03978HP, Lot # A339229, A340896, A344386.
Part No. K09-04000HP, Lot # A338208, A339231, A341504,
A344612, A341505, A341504.
Part No. K09-04017C, Lot # A337857
Part No. K09-04316H, Lot # A342071.
Part No. K09-04488A, Lot # A338228, A341118.
Part No. K09-04863C, Lot # A337204, A338112.
Part No. K09-04863C, Lot # A337204.
Part No. K09-04923B, Lot # A340508, A 343196.
Part No. K09-05138CP, Lot # A339425, A342802.
Part No. K09-05229G, Lot # A339926.
Part No. K09-05229GP, Lot # A345552.
Part No. K09-05477A, Lot # A342803.
Part No. K09-05785DP, Lot # A340897.
Part No. K09-05939C, Lot # A337947, A342379.
Part No. K09-05947D, Lot # A342670.
Part No. K09-06262P, Lot # A341604.
Part No. K09-07470C, Lot # A342173.
Part No. K09-07547B, Lot # A340375.
Part No. K09-07573AP, Lot # A344373.
Part No. K09-07573P, Lot # A342349.
Part No. K09-07589P, Lot # A347257, A347985.
Part No. K09-07629CP, Lot # A344853.
Part No. K09-07746A, Lot # A337319.
Part No. K09-07759, Lot # A341614.
Part No. K09-07779P, Lot # A344855, A347876.
Part No. K09-07847, Lot # A342385.
Part No. K09-07883B, Lot # A336474.
Part No. K09-07924AP, Lot # A346124.
Part No. K09-07943AP, Lot # A345851.
Part No. K09-07944A, Lot # A339427.
Part No. K09-08020B, Lot # A331903.
Part No. K09-08065P, Lot # A345570.
Part No. K09-08150AP, Lot # A340352, A342387.
Part No. K09-08214B, Lot # A340534
Part No. K09-08369, Lot # A342388.
Part No. K09-08391AP, Lot # A340252, A343600.
Part No. K09-08397, Lot # A335968.
Part No. K09-90270KP, Lot # A3412623, A343596.
Part No. K09-90358DP, Lot # A345692.
Part No. K09-MS2366H, Lot # A341693.
Part No. K09-MS2450B, Lot # A338759.
Part No. K09-MS2550A, Lot # A343809.
Part No. K09-MS2602A, Lot # A342813.
Part No. K09-MS2638B, Lot # A341694,
Part No. K09-MS2703B, Lot # A336929, A343808.
Part No. K10-01223B, Lot # A339948.
Part No. K10-03441P, Lot # A336328, A343551.
Part No. K10-03616, Lot # A339959.
Part No. K12-01176B, Lot # AS345883.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on September 14, 2004. Firm initiated recall is ongoing.
REASON
Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
VOLUME OF PRODUCT IN COMMERCE
20,452 syringes.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
CIDEX OPA Solution, ortho-Phthalaldehyde Solution. Recall # Z-0051-05.
CODE
Product Code: 20390, 20391, 20394.
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letters on April 23, 2004 and May 7, 2004. Firm initiated recall is ongoing.
REASON
Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
VOLUME OF PRODUCT IN COMMERCE
NA.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
BD Vactuainer SST glass and plastic tubes. Recall # Z-0052-05.
CODE
There is no linkage to any particular lot of BD product.
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Company, Franklin Lakes, NJ, by a Technical Bulletin on September 17, September 23, 2004 and October 5, 2004. Firm initiated recall is ongoing.
REASON
There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and adrenal gland function. The immunoassay results are high when BD serum separator tubes are used in certain instruments platforms.
VOLUME OF PRODUCT IN COMMERCE
Unspecified.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) MDA® Fibriquik™. Recall # Z-0053-05;
b) Fibriquik™. Recall # Z-0054-05.
CODE
a) Product number 252560, Lot number 505046;
b) Product number 235531, Lot number 113101, 113049,
113050 and Product number 235529, Lot number 111169.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on August 20, 2004. Firm initiated recall is ongoing.
REASON
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
VOLUME OF PRODUCT IN COMMERCE
3,571 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344. Recall # Z-0055-05.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated September 30, 2004. Firm initiated recall is ongoing.
REASON
Model GP344 may detach from the mounting block and fall during use.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CO, CT, NY, MD, MI, MN, NV, and UT.

_______________________________
PRODUCT
a) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1007. The product is shipped in cartons
containing 5 units. Recall # Z-0056-05;
b) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1009. The product is shipped in cartons
containing 5 units. Recall # Z-0057-05;
c) SafeSheath KR under the Pressure Products label. Tearaway KR Kit.
Catalog number HLS/KR-1011. The product is shipped in cartons
containing 5 units. Recall # Z-0058-05.
CODE
a) Lot number F4910 exp 12/05, Lot number F5678 exp. 4/06,
and Lot number F6251 exp. 6/06;
b) Lot number F5861 exp. 6/06 and Lot number 6724 exp. 8/06;
c) Lot number F6824 exp. 8/06.
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc., Malvern, PA, by letter on October 15, 2004. Firm initiated recall is ongoing.
REASON
Sheaths may fracture if exposed to excess fluorescent light.
VOLUME OF PRODUCT IN COMMERCE
2,770 kits.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Sterile Multi-Purpose Solution, NO RUB, for soft hydrophilic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals. Recall # Z-0060-05.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
K C Pharmaceuticals, Inc., Pomona, CA, by letters on October 4, 2004. Firm initiated recall is ongoing.
REASON
Routine testing indicates product does not meet the expiration date in all cases.
VOLUME OF PRODUCT IN COMMERCE
2,252,664.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Infusion Dynamics Power Infuser pump. Model number M100B-3A. Recall # Z-0062-05.
CODE
Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036.
RECALLING FIRM/MANUFACTURER
Infusion Dynamics, A Div. Of Zoll Med Corpinfusion Dynamics, Plymouth Meeting, PA, by letter dated September 20, 2004. Firm initiated recall is ongoing.
REASON
Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position
VOLUME OF PRODUCT IN COMMERCE
99 units.
DISTRIBUTION
TX, MO, VT, CA, NV, NY, pa, and Germany.

_______________________________
PRODUCT
Pagewriter Touch Cardiograph Software. Recall # Z-0063-05.
CODE
Software Versions A.01.01 or A.01.02.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is ongoing.
REASON
Software can generate printed ECG's that associate incorrect patient data with the waveform.
VOLUME OF PRODUCT IN COMMERCE
768 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) SOMATOM CT System Emotion Duo, X-Ray, Tomography, Computed System,
Model number 38 13 933. Recall # Z-0156-05;
b) SOMATOM CT System Emotion 6, Computed Tomography X-Ray System,Model
Number: 38 15 490. Recall # Z-0157-05;
c) SOMATOM CT System Sensation 16, Computed Tomography X-Ray, Model
Number 73 93 114. Recall # Z-0158-05;
d) SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography
System, Model Number 73 93 114. Recall # Z-0159-05;
e) SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray,
Model Number 75 43 106. Recall # Z-0160-05;
f) SOMATOM CT System Sensation Cardiac (+ Straton), Computed
Tomography X-Ray System, Model Numbers 75 43 106. Recall
# Z-0161-05;
g) SOMATOM CT System Sensation 10, Computed Tomography X-Ray System,
Model Number 75 43 015. Recall # Z-0162-05;
h) LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534.
Recall # Z-0163-05.
CODE
a) Serial Number 36716;
b) Serial Numbers: 43007, 43014, 43015, 43020, 43024, 43031, 43032,
43052, 43053, 43097, 43098, 43114, 43199, 43218, 43222, 43228,
43244, 43258, 43269, 43273, 43287, 43298, 43308, 43329, 43343,
43346, 43347, 43349, and 43361;
c) Serial Numbers: 50008, 50013, 50014, 50022, 50025, 50026, 50027,
50029, 50034, 50036, 50037, 50040, 50042, 50044, 50048, 50050,
50054, 50058, 50062, 50066, 50073, 50075, 50079, 50081, 50085,
50086, 50089, 50093, 50096, 50097, 50100, 50105, 50106, 50110,
50113, 50123, 50124, 50131, 50134, 50138, 50139, 50141, 50142,
50146, 50152, 50154, 50156, 50158, 50162, 50165, 50166, 50168,
50174, 50175, 50178, 50181, 50183, 50186, 50190, 50192, 50193,
50194, 50202, 50203, 50205, 50212, 50219, 50222, 50224, 50226,
50234, 50238, 50245, 50249, 50250, 50255, 50258, 50262, 50263,
50266, 50273, 50274, 50278, 50283, 50285, 50288, 50293, 50300,
50308, 50310, 50316, 50317, 50325, 50327, 50332, 50334, 50340,
50343, 50351, 50356, 50365, 50374, 50379, 50380, 50391, 50392,
50394, 50394, 50396, 50409, 50412, 50416, 50421, 50429, 50433,
50435, 50452, 50454, 50455, 50458, 50459, 50461, 50462, 50465,
50466, 50467, 50471, 50472, 50473, 50479, 50482, 50483, 50488,
50490, 50491, 50494, 50497, 50501, 50512, 50525, 50530, 50534,
50535, 50540, 50543, 50549, 50550, 50555, 50556, 50557, 50560,
50561, 50564, 50568, 50570, 50573, 50575, 50576, 50577, 50579,
50580, 50582, 50585, 50588, 50590, 50591, 50595, 50597, 50600,
50609, 50610, 50611, 50615, 50621, 50622, 50626, 50627, 50628,
50631, 50632, 50636, 50639, 50640, 50643, 50644, 50545, 50650,
50651, 50653, 50665, 50668, 50669, 50672, 50674, 50682, 50683,
50685, 50686, and 50999;
d) Serial Numbers: 51796, 51798, 51799, 51800, 51801, 51806, 51808,
51809, 51811, 51813, 51814, 51820, 51822, 51823, 51828, 51829,
51831, 51832, 51834, 51835, 51836, 51837, 51838, 51839, 51841,
51845, 51846, 51847, 51851, 51852, 51853, 51854, 51855, 51856,
51858, 51862, 51864, 51865, 51867, 51868, 51869, 51870, 51872,
51875, 51877, 51880, 51881, 51884, 51885, 51886, 51887, 51889,
51890, 51892, 51897, 51899, 51900, 51903, 51904, 51905, 51907,
51908, 51911, 51912, 51914, 51916, 51917, 51918, 51920, 51921,
51925, 51928, 51929, 51930, 51931, 51932, 51935, 51936, 51938,
51940, 51943, 51944, 51945, 51947, 51948, 51949, 51953, 51954,
51957, 51959, 51961, 51962, 51963, 51964, 51965, 51966, 51967,
51968, 51971, 51972, 51973, 51975, 51979, 51980, 51982, 51985,
51988, 51989, 51990, 51991, 51997, 51998, and 51999;
e) Serial Numbers: 52001, 52005, 52006, 52007, 52008, 52009, 52010,
52011, 52013, 52015, 52016, 52017, 52018, 52019, 52020, 52021,
52022, 52023, 52024, 52026, 52027, 52028, 52030, 52032, and 52033;
f) Serial Numbers: 52948, 52950, 52951, 52952, 52953, 52954, 52955,
52956, 52957, 52958, 52959, 52960, 52961, 52962, 52963, 52964,
52965, 52966, 52967, 52968, 52969, 52971, 52972, 52973, 52974,
52975, 52976, 52977, 52978, 52979, 52980, 52981, 52982, 52983,
52984, 52985, 52986, 52988, 52989, 58990, 52991, 52992, 52993,
52994, 52996, 52997, and 58999;
g) Serial Numbers: 53001, 53009, 53014, 53054, 53069, 53081, 53084,
53085, 53091, 53096, 53100, 53119, 53126, 53128, 53135, 53139,
53144, 53145, 53147, 53151, and 53154;
h) Serial Numbers: 6026, 6037, 6047, 6106, 6114, 6115, 6116, and
20014.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 28, 2004. Firm initiated recall is ongoing.
REASON
Calcium Scoring feature on the devices is not closing properly after patient's exams.
VOLUME OF PRODUCT IN COMMERCE
126 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Counterfeit contact lenses labeled as: "CooperVision Proclear compatibles (omafilcon A)". Labeling on outer box reads in part: "CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***". Recall # Z-0164-05.
CODE
(Identified as Lot number , power): 200218733K, -0.75; 200221583L, -1.00; 200221758L, -1.25; 200217599K, -1.50; 200219058K; -1.75; 200203444G, -2.00; 200217595K, -2.25; 200221190L, -2.50; 200219740K, -2.75; 200217588K, -3.00; 200323296A, -3.25; 200222445L, -3.50; 200325268A, -3.75; 200292234E, -4.00; 2002922484E, -4.00; 200213996J, -4.25; 200218908K, -4.50; 200214236J, -4.75; 200215709J, -5.00; 200212242J, -5.25; 200325303A, -5.50; 200213136J, -5.75; 200213135J, -6.00; 200208401H, -6.50; 200219479K, -7.00; and 200218545K, -7.50.
RECALLING FIRM/MANUFACTURER
1-800 Contacts Inc., Draper, UT, by letter on October 13, 2004. Firm initiated recall is ongoing.
REASON
Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
82,268.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) CryoValve, Pulmonary Valve & Conduit. Recall # Z-0165-05;
b) CryoValve, Aortic Valve & Conduit. Recall # Z-0166-05;
c) Alt Pulmonary Valve & Conduit. Recall # Z-0167-05;
d) CryoValve, Aortic Valve. Recall # Z-0168-05;
e) CryoValve, Pulmonary Valve & Conduit - SG. Recall # Z-0169-05;
f) CryoValve, Aortic Valve & Conduit w/o AML. Recall # Z-0170-05;
g) CryoValve, Pulmonary Valve. Recall # Z-0171-05;
h) CryoValve, Aortic Valve & Conduit SG. Recall # Z-0172-05;
i) Alt. Aortic Valve & Conduit. Recall # Z-0173-05
CODE
a) Donor #40003, Serial #6528309, Model #PV00*
Donor #40017, Serial #6528244, Model #PV00*
Donor #41194, Serial #6575765, Model #PV00*
Donor #41205, Serial #6575951, Model #PV00*
Donor #41983, Serial #6601316, Model #PV00*
Donor #45463, Serial #6708282, Model #PV00*
Donor #45539, Serial #6697697, Model #PV00*
Donor #45616, Serial #6735116, Model #PV00*
Donor #46477, Serial #6741538, Model #PV00*
Donor #46894, Serial #6768760, Model #PV00*
Donor #49793, Serial #6888973, Model #PV00*
Donor #50045, Serial #7110175, Model #PV00*
Donor #50982, Serial #7004457, Model #PV00*
Donor #50986, Serial #7048353, Model #PV00*
Donor #51902, Serial #7037079, Model #PV00*
Donor #59101, Serial #7387145, Model #PV00*
Donor #61954, Serial #7682701, Model #PV00;
b) Donor #25741, Serial #6048048, Model #PV00*
Donor #34696, Serial #6356176, Model #PV00*
Donor #40017, Serial #6528252, Model #AV00*
Donor #41180, Serial #6575609, Model #AV00*
Donor #41204, Serial #6575862, Model #AV00*
Donor #41737, Serial #6593488, Model #AV00*
Donor #45446, Serial #6714974, Model #AV00*
Donor #45592, Serial #6735875, Model #AV00*
Donor #46183, Serial #6736590, Model #AV00*
Donor #46484, Serial #6774373, Model #AV00*
Donor #46505, Serial #6770996, Model #AV00*
Donor #47518, Serial #6761788, Model #AV00*
Donor #50045, Serial #7110160, Model #AV00*
Donor #50098, Serial #7106597, Model #AV00*
Donor #50953, Serial #7000596, Model #AV00*
Donor #50982, Serial #7090443, Model #AV00*
Donor #53789, Serial #7013389, Model #AV00*
Donor #54935, Serial #7235057, Model #AV00*
Donor #59111, Serial #7343716, Model #AV00*
Donor #59407, Serial #7322607, Model #AV00;
c) Donor # 4039, Serial #6531822, Model #PV05;
d) Donor #46496, Serial #6741341, Model #AV10;
e) Donor #55634, Serial #7250375, Model #SGPV00*
Donor #60740, Serial #7756769, Model #SGPV00*
Donor #60758, Serial #7765469, Model #SGPV00*
Donor #60760, Serial #7753955, Model #SGPV00*
Donor #63969, Serial #7907208, Model #SGPV00*
Donor #64863, Serial #7865589, Model #SGPV00;
f) Donor #56596, Serial #7410328, Model #AV40;
g) Donor #59446, Serial #7352907, Model #PV10;
h) Donor #60727, Serial #7763406, Model #SGAV00*
Donor #62532, Serial #7818159, Model #SGAV00*
Donor #64863, Serial #7865603, Model #SGAV00*
Donor #65932, Serial #8105091, Model #SGAV00;
i) Donor #34698, Serial #6356222, Model #AV05.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter on/about May 6, 2004. Firm initiated recall is ongoing.
REASON
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
VOLUME OF PRODUCT IN COMMERCE
51.
DISTRIBUTION
Nationwide, Austria, Canada, Germany.

_______________________________
PRODUCT
a) Stryker brand Neptune waste management system, Neptune Rover, 20
amp plug; model 0700-001-000. Recall # Z-0174-05.
b) Stryker brand Neptune waste management system, Neptune Rover, 15
amp plug; model 0700-003-000. Recall # Z-0175-05.
CODE
a) All units with an Interpower brand AC power plug, which includes
serial numbers 0101014 through 03227006033.
b) All units with an Interpower brand AC power plug, which includes
serial numbers 0203177 through 0406301403.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Div. Of Stryker Corp., Kalamazoo, MI, by letter dated November 9, 2004. Firm initiated recall is ongoing.
REASON
The grounding pin may break inside of the electrical plug, resulting in a shock hazard.
VOLUME OF PRODUCT IN COMMERCE
1,682
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Alto and Alto 2 implantable cardioverter defibrillator. Recall # Z-0176-05.
CODE
Model Numbers DR model 614, VR model 615.
RECALLING FIRM/MANUFACTURER
ela Medical Llc, Plymouth, MMN, by letter, on October 21, 2004. Firm initiated recall is ongoing.
REASON
These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.
VOLUME OF PRODUCT IN COMMERCE
450 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; Model 7030 - Consisting of the Aeroneb Go, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7070 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual; Model 7000-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, European mask elbow, mouthpiece, carry bag, and user manual; Model 7030-1 - Consisting of the Aeroneb Go, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual; Model 7070-1 - Consisting of the Aeroneb Go, battery controller, battery controller cable, 3 AA alkaline batteries, AC wall adapter, European mask elbow, mouthpiece, carry bag, and user manual. 7000LINCARE - Consisting of the Aeroneb Go, battery controller with a Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, mask elbow, mouthpiece, carry bag, and user manual; 7070LINCARE - Consisting of the Aeroneb Go, battery controller with the Lincare private label cover plate, battery controller cable, 3 AA alkaline batteries, AC wall adapter, mask elbow, mouthpiece, carry bag, and user manual. Recall # Z-0177-05.
CODE
040120, 040127, 040129, 040130, 040201, 040202, 040203, 040205, 040209, 040210, 040216, 040219, 040227, 040301, 040303, 040305, 040311, 040317, 040406, 040407, 040415, 040427, 040421, 040428, 040506, 040721, 040723, 040726, 040730, 080504, 080904, 081104, 081604, 081704, 081904, 082004, 082304, 082504, 082704, 083004, 083104, 080304.
RECALLING FIRM/MANUFACTURER
Medical Industries America, Inc., Adel, ID, by telephone on September 7, 2004 and October 1, 2004 and by letters between September 24-28, 2004. Firm initiated recall is ongoing.
REASON
The nebulizer can either fail or provide a low flow (partial dose) of medication.
VOLUME OF PRODUCT IN COMMERCE
17,464 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system). Recall # Z-0178-05.
CODE
Part # 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) Site numbers: A42000896, A3B000796, A34000603, A2C000441, A32000483, A33000540, A28000273, A35000637, A35000649, A26000159, A45001061, A28000241, A37000732, A25000143, A35000663, A42000932, A32000505, A42000898, A33000546, A24000084, A26000165, A28000255, A28000266, A28000276, A45001050, A36000692, A45001066, A34000559, A24000052, A32000501, A2C000460, A3C000853, A34000582, A2A000350, A2C000458, A2B000408, A28000277, A27000197, A25000136, A33000550, A34000596, A24000104, A34000621, A33000549, A2B000374, A34000607, A43001003, A28000238, A34000568, A28000275, A36000674, A29000323, A2A000354, A29000318, A29000325, A27000188, A36000678, A28000253, A34000628, A27000204, A3B000804, A36000687, A3C000825, A25000140, A3B000799, A28000267, A2A000335, A2A000353, A31000489, A29000289, A2A000338, A39000780, A26000153, A35000636, A2A000348, A38000760, A42000916, A2B000395, A42000912, A24000101, A36000706, A35000665, A34000629, A42000907, A43001005, A25000131, A27000189, A25000123, A42000889, A2C000438, A2B000420, A28000231, A26000160, A37000735, A32000502, A34000595, A24000067, A42000885, A28000270, A24000054, A2B000358, A39000776, A2C000448, A3C000846, A24000087, A35000659, A2C000455, A39000769, A43001006, A26000161, A24000057, A42000945, A34000589, A37000723, A31000477, A31000488, A2B000411, A2C000440, A2C000452, A2C000456, A31000466, A31000467, A31000479, A31000480, A31000481, A32000509, A26000154, A27000181, A42000925, A33000523, A34000577, A3C000812, A29000290, A31000474, A34000602, A26000157, A2A000349, A42000901, A42000947, A23000047, A36000702, A25000146, A2A000345, A44001022, A28000280, A2C000449, A3C000850, A41000861, A24000060, A2A000330, A42000895, A27000212, A26000170, A27000192, A42000931, A37000738, A26000173, A26000179, A26000178, A29000300, A38000753, A39000783, A24000061, A2A000327, A27000186, A2C000463, A31000478, A2C000446, A31000492, A28000235, A28000229, A25000144, A2B000399, A27000198, A27000202, A2C000445, A34000588, A36000677, A3C000824, A43000982, A2B000365, A36000707, EMO00005, A36000705, A34000623, A26000176, A26000180, A25000106, A25000108, A25000115, A34000565, A34000578, A31000476, A32000504, A36000670, A2B000385, A3B000794, A2A000344, A36000694, A3B000806, A3C000826, A39000767, A42000899, A2C000437, A21000016, A25000118, A2C000444, A38000756, A37000720, A45001058, A37000721, A34000612, A32000490, A28000226, A28000260, A24000077, A25000111, A31000475, A33000534, A24000076, A25000116, A35000652, A31000470, A36000716, A35000630, A44001032, A41000872, A2C000451, A2C000457, A32000498, A29000319, A27000210, A24000051, A31000468, A34000557, A34000567, A3B000802, A42000934, A42000921, A35000650, A27000203, A23000040, A34000563, A21000018, A32000495, A36000717, A39000778, A24000096, A25000126, A26000164, A27000194, A42000893, A42000903, A32000515, A34000615, A34000616, A2C000439, A33000536, A34000587, A34000606, A32000507, A25000137, A24000056, A34000614, A25000133, A44001045, A25000147, A23000042, A35000664, A25000130, A25000148, A32000516, A34000611, A43000995, A37000736, A42000894, A31000482, A2A000331, A32000499, A43000980, A35000654, A44001019, A25000110, A34000556, A35000641, A35000642, A44001027, A44001028, A42000913, A3C000813, A42000928, A45001051, A2B000381, A2B000372, A2C000450, A32000513, A24000073, A3B000790, A34000597, A25000145, A31000493, A28000220, A34000627, A35000669, A28000265, A37000743, A35000645, A27000200, A29000310, A28000247, A26000171, A42000922, A27000184, A34000560, A28000243, A24000055, A35000644, A29000292, A21000015, A33000528, A32000517, A27000211, A28000257, A28000230, A2A000340, A34000599, A28000262, A2C000443, A2C000465, A35000643, A2A000337, A28000250, A31000491.
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA, by letter on September 6, 2004. Firm initiated recall is ongoing.
REASON
Potential for device to cause burning of the skin.
VOLUME OF PRODUCT IN COMMERCE
333 to domestic customers, 29 demos, 704 international.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Product code GU6397. Recall # Z-0179-05.
CODE
Lot number 1041194, exp. 2009/08.
RECALLING FIRM/MANUFACTURER
Cardinal Health, Medical Products & services, McGaw Park, IL, by letter dated October 27, 2004. Firm initiated recall is ongoing.
REASON
The dispenser box was mislabeled with the wrong length and the wrong wire gauge.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
SC, NY, MO, WV, TX and MS.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma. Recall # Z-1473-04.
CODE
Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05).
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated July 28, 2004. Firm initiated recall is ongoing.
REASON
The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
VOLUME OF PRODUCT IN COMMERCE
1) 5,912 cartons x 250 slides;
2) 10,344 x 90 slides.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
RESOLVE Hemoglobin Test Kits. Kit codes: FR-9120 -- 120 tests per kit; FR-9400 -- 360 tests per kit; and FR-9360 --3600 tests per kit. Recall # Z-0047-05.
CODE
FR-9120 - Lot Number: 243309 FR-9360 - Lot Numbers: 213926, 213932, 213939, 213944, 220789, 220794, 220804, 220809, 220799, 220814, 220819, 220824, 220829, 220834, 220839, 220848, 220855, 220860, 220865, 220870, 220875, 220882, 220892, 220898, 228304, 228309, 228314, 228319, 228325, 228330, 228335, 228341, 228348, 228353, 228358, 228363, 228368, 228374, 228379, 228386, 228391, 228396, 229401, 228406, 234161, 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234210, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 238917, 234267, 234272, 234277, 238920, 238923, 238926, 238929, 238932, 238946, 238950, 238953, 238960, 238963, 242331, 242334, 242334. FR-9400 - Lot Numbers: 213941, 220791, 220901, 220806, 220811, 220801, 220816, 220826, 220831, 220836, 220841, 220857, 220862, 220902, 220872, 220894, 220900, 228306, 228316, 228327, 228332, 228344, 228350, 228355, 228360, 228365, 228376, 228381, 228388, 228398, 228403, 228408, 2234192.
RECALLING FIRM/MANUFACTURER
Perkin Elmer LAS Inc., Norton, OH, by letter dated September 14, 2004. Firm initiated recall is ongoing.
REASON
The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.
VOLUME OF PRODUCT IN COMMERCE
873 test kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters. Recall # Z-0059-05.
CODE
Lot number RF4066579.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated September 27, 2004. Firm initiated recall is ongoing.
REASON
Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK.
VOLUME OF PRODUCT IN COMMERCE
290 kits.
DISTRIBUTION
KS, VA, AR, FL, and GA.

_______________________________
PRODUCT
Excelart™ VANTAGE P2 & P3, Magnetic Resonance Imaging System. Recall # Z-0061-05.
CODE
Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021, A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013, A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Systems, Inc., Tustin, CA, by letter on September 29, 2004. Firm initiated recall is ongoing.
REASON
Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR November 10, 2004

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