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U.S. Department of Health and Human Services

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Enforcement Report for May 9, 2007

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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May 9, 2007
07-19

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Egg protein (all flavors) ( Egg Protein III) in bulk, 2000 lbs batch, packed into plastic lined plastic boxes, 15kg each, Recall # F-231-7
CODE
Code #’s: 70102, 70103, 70134, 70135, 70136, 70162, 70153, 70164, 70179, 10180, 61078, 60833, 60853, 61087, 61145
RECALLING FIRM/MANUFACTURER
Quality Formulation Laboratories, Inc., Paterson, NJ, by letter, on January 31, 2007. Firm initiated recall is ongoing.
REASON
Product contains undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
29,421 lbs.
DISTRIBUTION
GA

___________________________________
PRODUCT
a) Knorr-Lipton Pasta Sides Chicken-Fettuccini in a Savory Chicken
Flavored Sauce Nt. Wt. 4.3 oz. (121 g) pouches UPC 0 41000 02246 3
Case Code UPC 41000 02246, Recall # F-232-7;
b) Knorr-Lipton Fiesta Sides - Spanish Rice Rice and Pasta Blend with
Bell Peppers in a Sweet Tomato Sauce. Nt. Wt. 5.6 oz, (158g)
UPC 0 41000 02268 5 Case Code 41000 02268L, Recall #F-233-7;
c) Knorr-Lipton Fiesta Sides Chipotle Rice Rice and Orzo Pasta Blend in a
Southwestern Smoked Chipotle Sauce. Nt. Wt. 5.7 oz. (161 g)
UPC Code 0 41000 02605 8 Case Code UPC41000 02605, Recall # F-234-7;
d) Knorr-Lipton Cajun Sides New Orleans Style Chicken Rice Rice and pasta blend
with Red Peppers, Chicken Flavor and Mild Cajun Spices Nt., Wt. 5.5 oz. (155 g)
UCP 0 41000 02609 6 Case Code UPC 41000 02609, Recall # F-235-7;
e) Knorr-Lipton Cajun Sides Dirty Rice A Delicious Rice and Pasta Blend
with Onions, Garlic and Mild Cajun Spices. Nt. Wt. 5.7 0z. (161 g)
UPC 0 41000 02280 7 Case Code UPC 41000 02280L, Recall # F-236-7;
f) Knorr-Lipton Rice Sides Chicken Rice and Pasta Blend in a Savory Chicken
Flavored Sauce. Nt. Wt. 5.6 oz. (158 g) UPC 0 41000 02266 1 Case Code
UCP 41000 02266L, Recall # F-237-7;
g) Knorr-Lipton Rice Sides Sesame Chicken Whole Grain Rice and Pasta
Blend in a Sesame Chicken Flavored Sauce. Nt. Wt. 5 oz. (141 g)
UPC # 0 41000 20920 8 Case Code UPC 41000 20920, Recall # F-238-7;
h) Knorr-Lipton Pasta Sides - Chicken Whole Grain Fettuccini in a Savory
Chicken Flavored Sauce. Nt.Wt. 4.4 0z (124 g) UPC 0 41000 20923 9
Case Code UP 41000 20923, Recall # F-239-7;
i) Knorr-Lipton Asian Sides - Thai Sesame Noodles Lo Mein Noodles in a
Soy Lemmongrass & Sesame Flavored Sauce. Nt. Wt. 4.4 oz. (124 g)
UPC 0 41000 02805 2 UPC Case Code 41000 02805, Recall # F-240-7
CODE
All Best By Dates
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ, by press release, telephone, e-mail, letter, and fax on October 3, 2006.
Manufacturer: Unilever Canada, Brampton, Canada. Firm initiated recall is ongoing.
REASON
Undeclared milk in certain Knorr-Lipton products.
VOLUME OF PRODUCT IN COMMERCE
6,972,533 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

___________________________________
PRODUCT
Grifulvin V® (griseofulvin) microsize oral suspension, 125 mg/5mL, 4 fl oz glass bottles, Rx only, NDC 0062-0206-04, Recall # D-791-2007
CODE
Lots: 5CA136, Exp. 03/31/2007; 5CA138, Exp. 03/31/2007; 5CA139, Exp. 03/31/2007; 5CA143, Exp. 03/31/2007; 5CA144, Exp. 03/31/2007; 5CA145, Exp. 03/31/2007; CA146, Exp. 03/31/2007; 5CA147, Exp. 03/31/2007; 5CA148, Exp. 03/31/2007; 5CA149, Exp. 03/31/2007; 5CA150, Exp. 03/31/2007; 5CA 151, Exp. 03/31/2007; 5CA164, Exp. 03/31/2007; 5CA165, Exp. 04/30/2007; 6CA616, Exp. 03/31/2008; 6DA636, Exp. 04/30/2008; 6DA637, Exp. 04/30/2008; 6DA638, Exp. 04/30/2008; 6DA640, Exp. 04/30/2008; 6DA646, Exp. 04/30/2008; 6DA647, Exp. 04/30/2008; 6DA648, Exp. 04/30/2008; 6DA649, Exp. 04/30/2008; 6DA657, Exp. 04/30/2008; 6EA670, Exp. 05/31/2008; 6GA731, Exp. 07/31/2008; 6HA846, Exp. 07/31/2008; 6HA851, Exp. 08/31/2008; 6HA868, Exp. 07/31/2008; 6HA873, Exp. 09/30/2008; 6HA874, Exp. 08/31/2008; 6JA936, Exp. 09/30/2008; 6JA937, Exp. 09/30/2008; 6KA987, Exp. 09/30/2008; 6KA988, Exp. 09/30/2008; 6KA989, Exp. 09/30/2008; 6MA193, Exp. 11/30/2008
RECALLING FIRM/MANUFACTURER
Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by letters on or about April 3, 2007. Firm initiated recall is ongoing.
REASON
Product may contain glass fragments.
VOLUME OF PRODUCT IN COMMERCE
1,010,480/4-fl. oz. bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
a) Platelets, Leukocytes Reduced, Recall # B-0905-07;
b) Platelets, Leukocytes Reduced, Irradiated, Recall # B-0906-07
CODE
a) Units: 022KL24055, 022FQ30594, 022KZ78973, 022FX19097, 022KV80542, 022KT75428, 022KN63437, 022FC30933, 022GH18918, 022KT75439, 022GE87550, 022GL26774, 022GE87545, 022KW68528, 022KN63445, 022FC30931, 022KT75444, 022KK74698, 022KL24064, 022FX19098, 022FX19098, 022KC77916, 022FS38663, 022KN63450, 022KW68565, 022GH18920, 022KL24096, 022KN63435, 022KV80568, 022LJ94383, 022KK74692, 022LJ94370, 022KW68557, 022KT75442, 022KW68529, 022KC77921, 022FS38699, 022FS38685, 022KV80557, 022KX76308, 022KN63443, 022GE87542, 022LJ94398, 022KV80562, 022KC77918, 022FQ30596, 022KL24073, 022KT75448, 022KV80544, 022LJ94372, 022KN63436, 022KL24089, 022LJ94377, 022KL24074, 022KC77922, 022KV80567, 022KW68559, 022GH18896, 022GL26772, 022KW68536, 022KL24057, 022FS38689, 022KW68571, 022KK74673, 022GL26778, 022KK74694, 022KT75447, 022KV80555, 022FC30935, 022FQ30591, 022KT75457, 022LJ94384, 022KK74669, 022KN63460, 022KX76329, 022KN63458, 022FQ30603, 022KL24065, 022LJ94391, 022KZ78987, 022KV80559, 022LJ94376, 022KT75436, 022KN63444, 022FQ30640, 022GH18950, 022FZ16851, 022FQ30647, 022KX76369, 022KZ79005, 022KX76349, 022GH18956, 022KV80604, 022FQ30630, 022FQ30638, 022LC24242, 022KC77957, 022KX76346, 022LC24236, 022LW84445, 022KC77958, 022GH18947, 022LJ94850, 022LW84443, 022GE87597, 022LW84451, 022KY97125, 022KY97120, 022KY97108, 022LJ94856, 022KY97104, 022KW68608, 022FQ30627, 022FZ16844, 022KC77956, 022KV80602, 022LW84444, 022KL24109, 022KC77964, 022FQ30631, 022KW68591, 022KX76356, 022LW84448, 022GE87593, 022LC24233, 022KZ79043, 022KW68658, 022FC31008, 022KC78015, 022LJ94975, 022LJ94940, 022GL26930, 022FQ30723, 022KW68665, 022GL26940, 022FQ30722, 022FZ16904, 022GL26893, 022KC77992, 022LJ94969, 022FZ16889, 022FZ16883, 022LJ94949, 022FQ30707, 022LW84509, 022KW68731, 022KW68738, 022KW68662, 022LJ94959, 022GL26928, 022LW84492, 022FQ30720, 022FQ30708, 022KY97164, 022KY97163, 022GL26899, 022KW68725, 022KZ77873, 022KZ77872, 022KC78011, 022KW68667, 022KZ77879, 022KW68739, 022KZ77851, 022KV80663, 022FZ16882, 022KW68664, 022FZ16879, 022KY97178, 022KW68671, 022KW68661, 022KW68742, 022FZ16898, 022KV80675, 022KZ77855, 022FC31026, 022KY97177, 022KZ77880, 022KC78009, 022FQ30639, 022LC24239, 022KL24105, 022KX76335, 022KX76338, 022KZ78999, 022KZ79011, 022GE87590, 022KL24118, 022FQ30636, 022KY97100, 022KZ78994, 022FC30960, 022KZ79009, 022KL24111, 022KZ78993, 022KZ78991, 022GH18955, 022GH18954, 022KL24115, 022FQ30633, 022LJ94836, 022LC24225, 022KL24107, 022GH18946, 022KL24100, 022KL24119, 022KC77931, 022KX76342, 022LC24247, 022KY97141, 022FS38756, 022KK74711, 022KW68649, 022KN63491, 022KN63497, 022LW84463, 022KN63503, 022LJ94891, 022KN63511, 022KK74715, 022FS38753, 022FS38735, 022KC77969, 022FS38755, 022KN63507, 022LJ94898, 022KL24168, 022KY97135, 022LJ94900, 022KN63506, 022KN63496, 022KN63500, 022GH18690, 022KZ79101, 022GL26822, 022KC77975, 022KN63505, 022KC77974, 022KZ79104, 022GH18684, 022KC77978, 022KN63512, 022KC77979, 022LW84465, 022KL24166, 022KW68646, 022KW68630, 022KW68641, 022LW84466, 022KY97133, 022LJ94893, 022KZ79103, 022KN63509, 022KN63508, 022KK74708, 022KK74720, 022GL26814, 022KY97143, 022KZ79102, 022KZ79100, 022KZ79105, 022KW68639, 022FS38746, 022KY97130, 022KX76436, 022KN63485, 022GL26817, 022KN63510, 022LJ94902, 022GL26900, 022KE23636, 022FQ30700, 022KW68680, 022FC31015, 022KW68687, 022LP08864, 022KV80666, 022KY97167, 022KV80674, 022GL26906, 022KE23645, 022LP08882, 022GL26897, 022KE23638, 022KV80670, 022GL26910, 022LW84502, 022KC77998, 022LW84498, 022LP08862, 022GL26908, 022KZ77857, 022KZ77864, 022KY97169, 022LP08863, 022LW84504, 022KX76440, 022KW68684, 022LW84495, 022FQ30698, 022LP08872, 022KC77991, 022LJ94962, 022KZ77849, 022FC31019, 022LJ94965, 022LP08883, 022KC77990, 022LW84514, 022GL26871, 022KC77989, 022KC77999, 022FC31018, 022KZ77846, 022KC77995, 022GL26907, 022LP08874, 022KC78026, 022LP08896, 022FQ30699, 022GL26883, 022LW84503, 022LP08867, 022GL26902, 022LW84493, 022LP08868, 022LW84515, 022FC31003, 022FQ30705, 022FS38650, 022LJ94802, 022FS38677, 022KT75411, 022LJ94807, 022KX76330, 022KN63456, 022FS38666, 022KT75422, 022KZ78961, 022KN63441, 022KW68551, 022FQ30587, 022KW68525, 022GE87541, 022FC30937, 022GH18914, 022LJ94389, 022KZ78959, 022FQ30589, 022GE87540, 022KL24081, 022LJ94805, 022KV80517, 022KZ78958, 022FC30941, 022FX19103, 022KT75424, 022KY97094, 022KN63462, 022FS38661, 022KL24076, 022FS38643, 022FX19115, 022KV80546, 022KX76327, 022GE87554, 022FS38691, 022KZ78962, 022KL24075, 022KY97121, 022LC24219, 022LW84435, 022KW68609, 022KX76373, 022LJ94878, 022GE87594, 022KV80589, 022KZ78992, 022KC77936, 022KW68594, 022GH18975, 022KL24140, 022KZ79052, 022KL24152, 022GE87626, 022FQ30629, 022KV80607, 022LW84446, 022LJ94867, 022GE87602, 022KV80606, 022LJ94848, 022KY97102, 022KW68612, 022KX76364, 022GE87580, 022KW68610, 022KL24132, 022KY97156, 022LJ94913, 022LJ94929, 022KV80638, 022KV80625, 022KW68645, 022KT75474, 022LJ94927, 022KZ79116, 022KN63499, 022FQ30690, 022KZ79128, 022FQ30665, 022KV80647, 022KV80640, 022LW84473, 022KX76428, 022KV80614, 022KZ79126, 022LW84469, 022KT75479, 022KZ79096, 022LJ94916, 022GH18674, 022KZ79115, 022LJ94922, 022LJ94926, 022GH18685, 022KW68650, 022KZ79122, 022FS38743, 022KW68648, 022KV80613, 022KT75480, 022KY97157, 022KV80659, 022KZ79125, 022GL26830, 022KZ79119, 022KT75470, 022LW84488, 022KW68577, 022KW68587, 022KW68585, 022KX76312, 022KW68579, 022KZ79022, 022KV80590, 022KZ79037, 022KZ79013, 022KV80599, 022FQ30651, 022KC78024, 022FC31017, 022LP08871, 022FC31028, 022FQ30706, 022FZ16884, 022FQ30585, 022GL26773, 022KT75450, 022KT75433, 022FS38705, 022GE87552, 022FQ30613, 022FC30939, 022FX19111, 022GL26784, 022LJ94394, 022KK74680, 022KC77911, 022KV80585, 022GE87546, 022FX19112, 022FX19134, 022KW68654, 022KY97134, 022KL24162, 022KW68657, 022KZ78978, 022KT75451, 022FX19102, 022KZ78976, 022FX19110, 022KN63465, 022KV80573, 022FS38695, 022KL24054, 022KN63463, 022LJ94888, 022GH18978, 022KV80603, 022LJ94879, 022GE87627, 022LP08889, 022FC31014, 022LP08877, 022LP08879, 022KX76457, 022KC78005, 022KV80678, 022KW68729, 022KW68730, 022FZ16887, 022LJ94968, 022KW68756, 022KW68728, 022FC31016, 022FZ16893, 022KV80512, 022KV80520, 022KV80515, 022KT75408, 022KW68570, 022FS38669, 022KC77926, 022GE87548, 022KZ79042, 022LJ94915, 022FC30992, 022KK74693, 022KZ78986, 022KL24093, 022KW68582, 022KK74684, 022KT75461, 022GE87571, 022LJ94810, 022FS38683, 022FX19120, 022KZ78981, 022KW68574, 022FX19126, 022KW68527, 022KZ78989, 022KZ78969, 022LJ94811, 022FS38690, 022FX19114, 022FS38713, 022KX76314, 022FS38712, 022KT75460, 022GH18917, 022KK74701, 022FS38693, 022FS38665, 022KZ78984, 022KV80582, 022KV80532, 022KT75453, 022FX19113, 022KT75459, 022GE87568, 022FQ30612, 022KY97093, 022KN63451, 022FC30942, 022FC30942, 022FC30924, 022FX19137, 022LC24208, 022FS38688, 022LJ94375, 022FX19130, 022LJ94378, 022KN63479, 022KK74702, 022KW68573, 022KT75455, 022LJ94385, 022FS38659, 022KN63446, 022KY97089, 022FS38686, 022KL24095, 022KX76347, 022GH18951, 022KX76375, 022FQ30644, 022LJ94835, 022FQ30616, 022KX76368, 022KW68611, 022GE87612, 022FQ30654, 022LJ94855, 022LJ94857, 022LJ94831, 022KL24138, 022KX76367, 022LJ94876, 022KZ79014, 022LJ94858, 022FQ30635, 022GE87632, 022KX76390, 022KX76354, 022FQ30632, 022LJ94861, 022KY97112, 022KZ79004, 022LJ94860, 022KX76351, 022KX76383, 022LJ94841, 022KX76460, 022LP08880, 022KW68734, 022KW68749, 022LJ94950, 022FC31004, 022FQ30710, 022KW68750, 022LP08895, 022LP08866, 022KX76449, 022LJ94951, 022LJ94967, 022KV80680, 022GL26936, 022KY97170, 022KX76454, 022FQ30713, 022KT75443, 022KW68544, 022KK74681, 022LC24198, 022KV80538, 022KV80541, 022KL24113, 022GH18942, 022KL24127, 022KC77944, 022KL24128, 022KL24125, 022KV80677, 022FZ16903, 022LJ94960, 022KV80681, 022KV80679, 022GL26919, 022KY97182, 022KX76442, 022LW84513, 022KX76446, 022KV80672, 022KV80570, 022KN63483, 022FQ30598, 022FS38662, 022KV80525, 022KL24058, 022LJ94804, 022LC24193, 022KC77917, 022LC24210, 022LC24213, 022KL24078, 022GH18921, 022FS38672, 022KC77920, 022KZ78974, 022KV80527, 022KL24056, 022KZ78971, 022KK74690, 022GH18913, 022GH18919, 022LJ94396, 022KC77924, 022KV80516, 022LJ94373, 022KV80545, 022KV80521, 022KC77928, 022KY97097, 022GH18932, 022LW84439, 022FZ16834, 022FC30961, 022GE87586, 022FQ30622, 022GH18971, 022KV80594, 022KW68600, 022KZ78997, 022KC77933, 022GE87584, 022GE87577, 022KZ78995, 022GH18933, 022KZ79000, 022GH18966, 022KY97101, 022KV80595, 022GE87583, 022KV80600, 022KV80597, 022GH18936, 022GE87614, 022KC77934, 022FZ16848, 022LC24241, 022LC24228, 022GE87617, 022GH18957, 022KZ79124, 022LW84485, 022KV80627, 022KT75481, 022LW84467, 022KZ79123, 022KL24187, 022KL24180, 022KZ79129, 022KZ79097, 022LJ94925, 022LW84477, 022LJ94897, 022KX76429, 022GL26852, 022FS38762, 022KX76430, 022KV80650, 022LJ94920, 022KT75476, 022KV80543, 022KZ78988, 022FX19109, 022FS38714, 022KW68537, 022KL24067, 022KX76331, 022GH18907, 022KV80529, 022LJ94382, 022KL24088, 022LJ94392, 022GE87558, 022KX76319, 022LJ94801, 022KL24085, 022KX76315, 022KN63480, 022KT75440, 022KX76310, 022KV80536, 022GL26776, 022KY97096, 022KZ78983, 022GH18906, 022KT75429, 022KW68532, 022LJ94808, 022KV80657, 022KV80651, 022KZ79112, 022LW84478, 022KV80656, 022KV80616, 022GL26843, 022KZ79131, 022KZ77877, 022KY97166, 022FZ16897, 022KW68675, 022KX76439, 022GL26868, 022KW68746, 022KV80687, 022KZ77871, 022FC31001, 022LW84511, 022KE23647, 022LP08878, 022GL26921, 022KV80665, 022KW68752, 022KE23639, 022LJ94964, 022FZ16896, 022KY97168, 022FS38656, 022KN63476, 022LC24195, 022FS38646, 022KV80514, 022FS38647, 022KZ79051, 022KL24141, 022KV80605, 022KZ79032, 022KX76377, 022LJ94877, 022KX76370, 022KW68614, 022GE87608, 022KX76380, 022KY97123, 022KY97115, 022KL24134, 022KV80593, 022KZ79049, 022LJ94887, 022KZ79039, 022KX76378, 022KZ77881, 022KY97181, 022KY97181, 022LJ94943, 022KE23651, 022KZ77875, 022LJ94939, 022LJ94852, 022KY97105, 022KX76382, 022LJ94886, 022GH18979, 022KX76381, 022KC77961, 022LW84441, 022GE87589, 022LC24222, 022KY97107, 022GH18953, 022KW68644, 022LC24204, 022KK74686, 022FX19117, 022FC30932, 022KC77914, 022KN63447, 022KL24070, 022KV80587, 022GE87569, 022KV80579, 022LJ94833, 022KZ79018, 022FC30963, 022KZ79019, 022KV80591, 022GE87609, 022GE87615, 022LW84442, 022KL24153, 022KZ79050, 022KZ79001, 022KY97113, 022KY97111, 022KZ79006, 022LC24244, 022KX76352, 022GE87611, 022KX76391, 022KX76365, 022KX76341, 022KV80566, 022KY97092, 022KV80588, 022KT75421, 022KZ78964, 022KV80560, 022KV80535, 022FS38667, 022FQ30592, 022LJ94387, 022FS38657, 022LW84428, 022KW68533, 022KT75420, 022LC24216, 022LJ94803, 022KV80563, 022FC30938, 022KN63457, 022GH18910, 022FC30926, 022KV80577, 022KT75449, 022KC77923, 022FQ30605, 022KW68581, 022KK74691, 022FX19101, 022FS38681, 022KV80561, 022KV80556, 022KZ78975, 022KV80522, 022KL24087, 022KV80553, 022KW68552, 022KN63442, 022FS38670, 022KL24082, 022KT75454, 022LW84427, 022KV80547, 022LJ94386, 022KT75430, 022KV80564, 022GE87560, 022KK74685, 022FS38668, 022KY97098, 022FQ30597, 022KV80558, 022LC24205, 022LC24214, 022KW68538, 022KV80565, 022FS38709, 022KW68586, 022FX19133, 022KL24084, 022FQ30599, 022GH18908, 022KN63454, 022LJ94368, 022FQ30609, 022LJ94809, 022FQ30606, 022FS38696, 022KT75456, 022GE87556, 022KZ78955, 022FS38707, 022GE87559, 022KZ78977, 022KT75418, 022FS38644, 022GE87555, 022KV80569, 022KT75434, 022FS38682, 022KZ79026, 022KZ79027, 022GH18968, 022KX76366, 022LJ94854, 022GH18965, 022KW68607, 022FZ16843, 022KZ79012, 022KX76361, 022KY97129, 022GH18944, 022KL24148, 022KW68605, 022KX76389, 022FQ30642, 022KL24112, 022GH18929, 022KY97128, 022KZ79054, 022LJ94840, 022GE87606, 022FZ16850, 022GH18961, 022FQ30628, 022KX76379, 022KL24133, 022LC24238, 022KZ79048, 022GH18977, 022LJ94844, 022GE87581, 022KV80592, 022KZ79044, 022KW68598, 022GH18972, 022KL24126, 022LJ94845, 022LJ94832, 022LC24246, 022KZ79007, 022GH18974, 022KZ78996, 022GE87616, 022GH18952, 022FQ30656, 022FQ30652, 022KY97145, 022KN63486, 022GL26813, 022KK74706, 022KX76418, 022LJ94890, 022KL24161, 022KX76423, 022KK74729, 022FS38739, 022KC77968, 022KL24171, 022KL24197, 022KK74714, 022FQ30668, 022FS38736, 022KL24190, 022KL24196, 022KX76419, 022KL24193, 022GH18679, 022KW68633, 022FS38748, 022FS38761, 022KX76426, 022GH18680, 022LW84474, 022KW68647, 022KL24189, 022FC30973, 022KZ79106, 022KL24192, 022LJ94889, 022KT75471, 022KZ77852, 022KW68683, 022GL26925, 022LP08861, 022KW68659, 022KV80669, 022KW68670, 022KY97174, 022KC78017, 022GL26931, 022GL26920, 022KY97160, 022KX76452, 022KY97183, 022KW68685, 022LJ94944, 022GH18901, 022KL24083, 022KV80540, 022FX19099, 022KN63440, 022KN63453, 022KN63448, 022KK74689, 022GH18905, 022KV80548, 022KW68535, 022KV80552, 022KL24094, 022KX76309, 022KN63434, 022FQ30601, 022KW68566, 022KT75410, 022KT75413, 022KV80534, 022KX76332, 022LJ94812, 022FC30929, 022FS38660, 022FQ30600, 022LC24200, 022GE87561, 022KT75452, 022KN63478, 022FS38698, 022FS38652, 022KK74687, 022FS38654, 022LC24211, 022GE87557, 022LC24207, 022KW68561, 022GH18904, 022KW68524, 022FS38653, 022FS38687, 022FC30928, 022KW68542, 022KW68543, 022GH18912, 022LC24194, 022KT75412, 022KX76326, 022KT75438, 022FS38658, 022KW68555, 022GH18922, 022LJ94388, 022GE87562, 022KT75437, 022GH18903, 022GE87620, 022LW84454, 022LW84457, 022KL24156, 022LJ94885, 022LJ94874, 022LJ94839, 022KZ79029, 022KV80609, 022LJ94842, 022KZ79053, 022KZ79041, 022FQ30646, 022KV80598, 022KZ79023, 022KY97114, 022KL24124, 022KL24131, 022KC77952, 022KZ79021, 022KC77960, 022KL24146, 022LJ94838, 022KL24117, 022KX76387, 022KZ79033, 022GH18940, 022GE87628, 022GE87613, 022GH18941, 022FQ30645, 022GH18982, 022KV80610, 022KC77938, 022FC30972, 022KK74727, 022LJ94919, 022KL24185, 022GL26839, 022FQ30693, 022KY97132, 022FS38760, 022KY97131, 022GH18694, 022FS38758, 022FC30977, 022LW84482, 022LJ94907, 022KV80642, 022KT75463, 022LJ94908, 022KN63487, 022KK74722, 022KL24188, 022LJ94912, 022KK74705, 022LJ94932, 022KK74725, 022LW84487, 022FC30976, 022KL24186, 022FS38771, 022KZ79130, 022KY97147, 022FC30968, 022GL26853, 022KL24191, 022KV80649, 022GL26819, 022KV80652, 022KL24198, 022KV80632, 022KV80622, 022KX76420, 022LW84475, 022KW68655, 022KW68640, 022LJ94918, 022KV80635, 022KV80648, 022GL26845, 022KZ79108, 022KW68636, 022GL26816, 022KL24182, 022KZ79127, 022LJ94911, 022FS38764, 022KW68631, 022FC30979, 022KY97154, 022KL24181, 022KT75477, 022KZ79110, 022KC77985, 022LW84470, 022FQ30685, 022FQ30683, 022GL26840, 022KK74726, 022KV80637, 022GL26835, 022LJ94928, 022GL26892, 022LP08897, 022GL26939, 022KV80676, 022LP08893, 022GL26937, 022KX76443, 022LP08887, 022KZ77868, 022FZ16899, 022GL26870, 022GL26890, 022KC78007, 022KV80688, 022KW68733, 022LP08869, 022GL26926, 022LJ94957, 022GL26911, 022GL26922, 022KW68727, 022GL26914, 022KE23640, 022GL26935, 022LC24212, 022KZ78952, 022KT75426, 022KX76317, 022KW68534, 022KV80519, 022KN63449, 022LW84430, 022KZ78960, 022KT75414, 022KN63466, 022GE87564, 022KT75415, 022GL26783, 022LJ94830, 022KY97118, 022FZ16847, 022GH18938, 022KL24135, 022KZ79035, 022KC77942, 022LC24245, 022KY97126, 022KX76388, 022KW68740, 022LP08873, 022LW84499, 022FZ16895, 022LP08890, 022LP08885, 022KZ77869, 022KW68753, 022KW68548, 022KW68567, 022KV80528, 022FQ30590, 022LC24201, 022KK74700, 022KV80533, 022KT75445, 022KK74695, 022KZ78965, 022KV80531, 022KT75435, 022FS38675, 022LC24199, 022FQ30610, 022KV80524, 022FQ30608, 022LC24217, 022KN63484, 022FQ30595, 022KZ79034, 022GE87587, 022LC24235, 022GE87588, 022KX76376, 022KW68604, 022GH18960, 022KC77948, 022KY97122, 022KY97124, 022KZ79028, 022KW68589, 022KL24149, 022LJ94870, 022KX76372, 022GE87592, 022GH18983, 022GH18976, 022KY97116, 022FQ30634, 022FQ30662, 022KZ79132, 022FS38742, 022KK74731, 022KY97148, 022KY97159, 022KV80636, 022GL26837, 022KY97151, 022KY97155, 022KX76427, 022KZ79133, 022GL26815, 022LJ94906, 022KV80628, 022FQ30667, 022KY97153, 022KV80653, 022FS38768, 022FS38769, 022LP08875, 022LP08876, 022KW68688, 022LP08881, 022FQ30717, 022KV80518, 022KT75427, 022KT75416, 022KZ78957, 022FS38671, 022GE87543, 022LC24196, 022KN63482, 022FC30936, 022KV80523, 022KZ78954, 022FQ30588, 022KV80513, 022GE87539, 022KL24080, 022KN63481, 022KZ78956, 022GE87578, 022KX76336, 022LC24240, 022KX76360, 022FQ30653, 022FQ30615, 022LJ94864, 022LJ94834, 022GE87600, 022GH18934, 022KX76371, 022KL24130, 022KX76386, 022KZ79045, 022FZ16853, 022LW84447, 022FZ16846, 022GE87582, 022GE87604, 022KZ79030, 022KC77935, 022KX76344, 022LJ94846, 022LW84455, 022KL24104, 022FQ30618, 022KX76343, 022FQ30621, 022KX76340, 022LW84456, 022KZ79010, 022LC24232, 022KV80596, 022LC24243, 022KX76339, 022KX76363, 022KX76337, 022GE87622, 022FZ16854, 022KX76345, 022FQ30623, 022LW84508, 022LJ94937, 022KC78018, 022GL26916, 022KC78010, 022FC31009, 022LW84507, 022GL26915, 022KV80661, 022GL26913, 022LJ94941, 022KW68673, 022KL24164, 022KL24165, 022KX76422, 022GH18688, 022KK74721, 022FQ30669, 022KC77959, 022LC24224, 022LJ94873, 022GE87603, 022KZ79040, 022KL24098, 022FQ30648, 022LJ94862, 022LJ94863, 022KX76432, 022LW84489, 022GL26849, 022KV80641, 022KX76434, 022LJ94905, 022FS38741, 022KZ78967, 022KW68550, 022FQ30611, 022FS38708, 022KW68576, 022FS38684, 022FS38649, 022FS38680, 022KW68569, 022LC24197, 022KT75431, 022LC24209, 022KZ78966, 022KV80581, 022KL24129, 022GH18981, 022KW68597, 022KC77932, 022FQ30657, 022KY97127, 022LW84438, 022KC77963, 022LJ94882, 022KX76374, 022FQ30643, 022LW84436, 022KW68562, 022GL26786, 022KL24091, 022KW68526, 022GE87621, 022GE87618, 022KC77946, 022GH18973, 022GH18939, 022GE87634, 022LJ94866, 022GH18980, 022FS38774, 022KK74724, 022KN63504, 022KK74718, 022KW68638, 022KX76424, 022KW68653, 022LP08870, 022KZ79117, 022KV80630, 022LJ94933, 022LJ94935, 022KL24195, 022LJ94931, 022KV80619, 022LJ94924, 022KL24143, 022GH18945, 022KX76350, 022KY97110, 022GE87633, 022KL24150, 022KW68732, 022GL26869, 022KW68747, 022KZ77870, 022LJ94945, 022LJ94961, 022GL26782, 022GH18916, 022GH18911, 022KK74675, 022KN63470, 022LJ94397, 022KC77927, 022KW68523, 022LJ94395, 022GH18909, 022KN63461, 022KL24060, 022KL24063, 022KN63459, 022KL24068, 022GL26775, 022GL26779, 022LJ94369, 022LC24231, 022LC24227, 022GE87607, 022LW84450, 022LW84437, 022GE87605, 022FZ16852, 022GE87596, 022FQ30692, 022FS38763, 022KW68651, 022KL24169, 022KL24163, 022KW68676, 022LJ94948, 022KW68672, 022KW68681, 022KW68674, 022KW68682, 022KW68666, 022KW68669, 022LJ94936, 022KZ79036, 022FC30962, 022LJ94843, 022KX76358, 022GE87599, 022KZ79024, 022FQ30637, 022FQ30641, 022KX76362, 022KZ79008, 022KX76459, 022GL26934, 022KX76450, 022FZ16902, 022KW68724, 022KX76456, 022GL26927, 022KW68726, 022KV80576, 022FS38711, 022KT75458, 022FX19121, 022KV80583, 022KW68545, 022KV80571, 022FS38700, 022FX19118, 022FX19123, 022KV80572, 022FX19132, 022GE87566, 022FX19127, 022FX19131, 022KV80580, 022FS38676, 022KW68546, 022KV80549, 022KW68578, 022KV80578, 022KV80574, 022KT75441, 022FS38710, 022FS38703, 022KZ78980, 022KK74696, 022KZ78979, 022KZ78982, 022FS38706, 022KX76355, 022GE87631, 022GH18963, 022LJ94868, 022GH18949, 022GH18964, 022KV80601, 022KL24145, 022GH18962, 022KL24136, 022LJ94853, 022LW84449, 022KV80608, 022LJ94847, 022KX76348, 022KZ77853, 022KZ77861, 022KE23648, 022FZ16881, 022KC78023, 022KE23641, 022FZ16880, 022KV80662, 022KC78025, 022KV80673, 022KL24160, 022FC31029, 022KV80667, 022KZ77858, 022KZ77874, 022KX76448, 022FC31024, 022KV80682, 022FC31022, 022KZ77865, 022KE23650, 022LJ94956, 022FZ16891, 022KW68539, 022KT75432, 022FS38674, 022FS38673, 022KW68554;

b) Units: 022FC30930, 022KK74699, 022GH18898, 022KN63474, 022GH18900, 022KX76313, 022KW68541, 022KW68531, 022KX76334, 022KN63433, 022GL26780, 022GH18902, 022FC30984, 022LW84476, 022KV80643, 022KZ79109, 022FS38775, 022LW84484, 022KW68642, 022GH18692, 022GL26823, 022GH18693, 022FS38773, 022GH18691, 022KK74710, 022FQ30664, 022KK74716, 022FQ30660, 022FQ30687, 022KT75425, 022GH18897, 022KL24069, 022LJ94374, 022GL26785, 022KT75417, 022GL26781, 022KX76325, 022FC30927, 022KX76318, 022GE87630, 022FQ30649, 022KZ79047, 022KL24139, 022KW68603, 022LJ94837, 022KW68606, 022KZ79046, 022LW84484, 022KL24110, 022KL24116, 022KL24108, 022KL24114, 022KN63473, 022KN63469, 022GH18683
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated June 28, 2006. Firm initiated recall is ongoing.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,655 units
DISTRIBUTION
PA, NJ, MD and Puerto Rico

___________________________________
PRODUCT
Source Plasma, Recall # B-0938-07
CODE
Units: 364016502, 364016368, 364015971, 364015792, 364015435, 364015246, 364014939, 364014751, 364014316, 364014130, 364013734, 364012959, 364012230, 364011986, 364011554, 364011318, 364010873, 364010651, 364010101, 364009870, 364009270, 364009094, 364006342, 364006091, 364005719, 364005466, 364005084, 364004870, 364004371, 364004160, 364003441, 364002852, 364007622, 364002281, 364001146, 172060279, 172059880, 172059273, 172058289, 172058187, 172058629, 172048493, 172048006, 172056828, 172056209, 172055764, 172055626, 172055132, 172055018, 172054536, 172054262, 172053783, 172053575, 172053014, 172052785, 172052416, 172049959, 172049740, 172049243, 172049035, 172048578, 172047864, 172047397, 172047194, 172046755, 172046539, 172046089, 172045891, 172045523, 172045267, 172051036, 172050798, 172050023, 172044645, 172044416
RECALLING FIRM/MANUFACTURER
International BioResources L.L.C., Fort Worth, TX, by fax on September 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who possibly received a body piercing within a year of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
NC

___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0944-07;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0945-07
CODE
a) Units: 23152-8477, 23152-8729, 23152-9571, 23152-8441,
23152-8899, 23152-9549;
b) Unit: 23152-8872
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters dated October 10 and 11, 2004 and follow-up letter dated January 18, 2005.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood Products, labeled "leukoreduced" which were not tested to verify the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MT, NV and CA

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0953-07
CODE
Unit: 0902874
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on April 19, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled "leukoreduced" which was not tested to verify the White Blood Cell (WBC) count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1057-07
CODE
Unit: 23153-7195
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters dated November 9, 2005 and December 30, 2005.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for Cytomegalovirus (CMV), but labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT

___________________________________
PRODUCT
Source Plasma, Recall # B-1075-07
CODE
Units: 0330042965, 0330043101, 0330043517, 0330043742, 0330044097, 0330044344, 0330044689, 0330044890, 0330045725, 0330046889, 0330050230
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., City of Industry, CA, by facsimile on December 29, 2004 and by letter dated December 30, 2004.
Manufacturer: Biomat USA, Inc., Seattle, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
Source Plasma, Recall # B-1220-07
CODE
Units: RM123484, RM123299, RM122881, RM122574, RM122389, RM121972, RM121368, RM121226, RM119947, RM119705, RM119528, RM119269, RM118860, RM118279, RM118215, RM123819, RM136451, RM134939, RM132210, RM131857, RM131703, RM131484, RM131179, RM131068, RM130844, RM130699, RM130496, RM130382, RM130175, RM130037, RM129773, RM129648, RM129259, RM125399, RM124970, RM124768, RM129029, RM128855, RM128518, RM128370, RM128066, RM128026, RM127692, RM127632
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Hattiesburg, MS, by facsimile on August 31, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of exposure to hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
CA, NY, NC, VA and Belgium

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1230-07;
b) Recovered Plasma, Recall # B-1231-07
CODE
a) and b) Units: 2286391, 2288541, 5136017
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile dated January 4, 2005, January 12, 2005, and January 19, 2005. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL, TX, and Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1234-07;
b) Recovered Plasma, Recall # B-1235-07
CODE
a) and b) Unit: 26GG10005
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Alabama Region, Birmingham, AL, by telephone and email on May 4, 2006, and by letter on May 8, 2006.
Manufacturer: American National Red Cross, Gulf Coast Region, Mobil, AL. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and CA

___________________________________
PRODUCT
Source Plasma, Recall # B-1239-07
CODE
Units: 90002025 and 90003068
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., dba Biomat USA, Inc., Clarksville, TN, by facsimile on December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1247-07;
b) Fresh Frozen Plasma, Recall # B-1248-07;
c) Recovered Plasma, Recall # B-1249-07
CODE
a) Units: 41FT71985, 41FT64615;
b) Unit: 41FT71985;
c) Unit: 41FT64615
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone or electronic notification on January 3, 2004, and by letters dated January 9, 2004 or January 12, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL and CA

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1252-07
CODE
Unit: 7119081
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile transmission dated October 6, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1254-07
CODE
Units: 2065601 – parts A and B
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on September 8, 2005, and by facsimile dated October 27, 2005. Firm initiated recall is complete.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1255-07
CODE
Units: 5766553 – parts A and B
RECALLING FIRM/MANUFACTURER
New York Blood Center, New York, NY, by letter dated September 25, 2003. Firm initiated recall is complete.
REASON
Platelets with a low platelet count, were distributed.,
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

___________________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-1257-07
CODE
Units: 22KE27554, 22KE27609, 22KE27597, 22KE27605, 22LC26650, 22KK75844, 22KW70703, 22LC26654, 22GL30423, 22KE27596, 22LW85665, 22KE27535, 22FZ21366, 22LJ99050, 22LW85643, 22GL30458, 22KK75837, 22KK75828, 22KE27592, 22KE27602, 22LW85648, 22GL30416, 22KE27607, 22KE27601, 22KE27594, 22GL30426, 22LC26660, 22GL30450, 22KE27606, 22KV84535, 22KW71034, 22KV84684, 22LJ99621, 22FX23344, 22LP11521, 22LP11505, 22LC26902, 22GE90265, 22LP11510, 22FX23338, 22FX23339, 22FX23334, 22KC81561, 22FS41388, 22KV84692, 22KW71035, 22FZ20593, 22KK76832, 22LJ99627, 22KV84698, 22FC34903, 22GM01338, 22FS41389, 22FC34883, 22LC26906, 22LP11518, 22KW71040, 22LP11512, 22GE90245, 22KV84739, 22KN66314, 22KX79636, 22GL31206, 22FZ20090, 22GS19697, 22KZ83648, 22LJ99708, 22LJ99721, 22KX79632, 22GE90305, 22LP11565, 22LJ99692, 22GS19688, 22LP11561, 22FX23370, 22GM01379, 22KN66316, 22GE90314, 22LP11582, 22FZ20095, 22LP11579, 22KX79641, 22KN66333, 22GM01365, 22LP11588, 22FZ20072, 22FZ20089, 22FX23362, 22FS41411, 22LJ99723, 22GE90294, 22FZ20073, 22KX79630, 22KC80815, 22KX79625, 22GM01369, 22FS41395, 22KC80812, 22FX23351, 22GE90306, 22LP11591, 22FS41412, 22KZ83646, 22KX79612, 22LJ99689, 22KX79620, 22KX79627, 22KZ83643, 22FS41407, 22FX23350, 22KX79634, 22KX79631, 22GL31202, 22KX79642, 22LJ99699, 22KC80810, 22LJ99696, 22FC34933, 22LP11575, 22FS41415, 22KC80817, 22FS41413, 22GL31225, 22GS19702, 22KE28205, 22KC80820, 22KN66311, 22KN66326, 22FS41410, 22GS19700, 22KT78633, 22LJ99726, 22KX79614, 22KT78625, 22KT78630, 22FC34931, 22LP11568, 22KN66310, 22GE90310, 22FC34934, 22FQ33674, 22FS41409, 22FX23361, 22KX79619, 22GL31221, 22GE90301, 22KE28206, 22LJ99663, 22FZ20097, 22LJ99682, 22LJ99686, 22KX79845, 22KX79624, 22KE28214, 22KE28195, 22LJ99671, 22KE27563, 22KZ83487, 22KE27565, 22GL30398, 22KE27603, 22GL30401, 22KW70699, 22KW70702, 22LC26656, 22GL30436, 22KE27595, 22KE27590, 22GL30399, 22KE27528, 22KE27562, 22KZ83490, 22KE27600, 22LJ99051, 22KE27591, 22KE27556, 22GL30447, 22KW70704, 22LJ99045, 22KE27599, 22GE90278, 22KC81582, 22KT78610, 22KV84690, 22KN63842, 22KC81584, 22LP11515, 22GE90242, 22KC81586, 22LP11495, 22KT78613, 22LJ99638, 22LC26900, 22KW71063, 22GE90239, 22LP11516, 22LJ99619, 22KN63819, 22GL31195, 22KV84677, 22LP11509, 22KC81573, 22LC26898, 22KK76825, 22FZ20074, 22FS41393, 22FX23356, 22LP11580, 22FZ20083, 22GM01378, 22FC34825, 22LP11557, 22GS19683, 22LP11559, 22KX79613, 22GM01383, 22FZ20075, 22FC34936, 22FZ20078, 22FZ20086, 22KC83136, 22FS41083, 22LW85661, 22GL30414, 22GM00667, 22KK75883, 22FS41418, 22LP11551, 22FQ33670, 22FX23358, 22LP11552, 22FZ20077, 22FZ20105, 22KT78616, 22FS41408, 22LP11550, 22FS41406, 22FQ33677, 22LJ99044, 22LJ99054, 22KC83134, 22LJ99047, 22LJ99052, 22LC26655, 22LJ99559, 22LC26905, 22GL31191, 22FS41382, 22KN63814, 22KW71050, 22GE90263, 22LP11496, 22FX23335, 22FX23329, 22GE90273, 22KW71046, 22LJ99643, 22LJ99633, 22GM01339, 22GE90282, 22LP11540, 22LP11537, 22FS41377, 22GL31146, 22KW71052, 22LP11527, 22KN63821, 22LP11506, 22FX23363, 22FX23364, 22FZ20092, 22KC80821, 22FX23366, 22FC34534, 22GS19069, 22GS19072, 22FC34336, 22KV84745, 22LJ99622, 22KV84743, 22LJ99624, 22KV84737, 22KC81577, 22LP11542, 22KW71069, 22KC81595, 22GL31214, 22KT79616, 22GS19031, 22GM00891, 22GL30432, 22KW70690, 22GL30424, 22GL30406, 22KN65896, 22FZ21361, 22FZ21380, 22KK75855, 22FC34539, 22FC34531, 22FZ21377, 22GL30410, 22LC26652, 22KC83132, 22LJ99037, 22GL31161, 22KW71055, 22FZ20595, 22GL31193, 22GL31192, 22KV84701, 22GE90260, 22FC34897, 22KN63818, 22GL31163, 22FZ20087, 22LJ99684, 22FQ33673, 22LP11571, 22KN66332, 22FC34940, 22KC80819, 22FC34919, 22KX79638, 22GE90296, 22KE27520, 22LJ99043, 22KK75826, 22LW85647, 22LW85644, 22KE27521, 22KT78646, 22KN63816, 22LW85664, 22KK75821, 22KE27549, 22FS41079, 22GM00890, 22FC34551, 22GE90021, 22KV84550, 22KE27542, 22KE27512, 22LW85668, 22KE27566, 22FC34538, 22GS19064, 22LJ99042, 22KK75818, 22KE27537, 22GS19017, 22KN65900, 22LW85649, 22GL30425, 22FC34540, 22KZ83480, 22KN65908, 22KV84537, 22FC34548, 22KW70691, 22KW70694, 22KN66327, 22FC34935, 22KC80823, 22LJ99697, 22KN66308, 22LJ99678, 22LJ99713, 22KX79653, 22KN66322, 22KN66328, 22GE90292, 22FS41419, 22GE90328, 22FX23348, 22LJ99680, 22GS19035, 22GS19029, 22GS19030, 22LJ99734, 22GL31218, 22LJ99707, 22KX79633, 22LJ99702, 22LJ99715, 22KN66323, 22KC80818, 22FX23355, 22FZ20106, 22FZ20098, 22LJ99681, 22LW85650, 22GS19055, 22KK75875, 22GS19026, 22KK75879, 22KK75849, 22GS19039, 22FS41080, 22FZ21391, 22KK75862, 22GE90241, 22FZ20587, 22GL31190, 22KV84691, 22LP11539, 22KV84726, 22KN63807, 22GL31183, 22KK76626, 22GL31150, 22GL31208, 22GS19686, 22LJ99725, 22GE90309, 22KT78619, 22KE28208, 22FQ33675, 22LP11580, 22FX23368, 22KC81694, 22KZ83849, 22KN66309, 22KZ83841, 22LJ99730, 22LJ99724, 22KZ83645, 22FQ33671, 22GM01385, 22LJ99710, 22GL31204, 22GL31197, 22KV84734, 22KV84706, 22KN63827, 22FS41379, 22FX23326, 22FZ20565, 22FX23221, 22KW71056, 22FS41384, 22LP11513, 22LC26827, 22KK76840, 22KX79647, 22LF11540, 22GE90295, 22FQ33676, 22KT78635, 22FQ33668, 22GM01372, 22FQ33679, 22GM01386, 22FC34930, 22KN66313, 22KT78631, 22KK75886, 22KK75869, 22FC34520, 22KK75886, 22KK75885, 22KE27584, 22KE27587, 22KK75880, 22FC34537, 22KK75847, 22KK75861, 22KE27566, 22FZ20101, 22GE90315, 22GE90326, 22FX23360, 22FQ33672, 22KX79954, 22FC34902, 22FS41392, 22GL31185, 22KW71067, 22GE90246, 22GE90249, 22LW85666, 22GS19051, 22GS19063, 22GS19049, 22KK75863, 22FC34550, 22GL30412, 22FC34541, 22KV84536, 22GS19053, 22GS19062, 22KK75830, 22GS19037, 22FS41086, 22KW70689, 22KE27604, 22KZ83468, 22FC34549, 22GS19024, 22GS19018, 22KN63841, 22KT78611, 22LJ99553, 22KT78612, 22FZ20588, 22LJ99651, 22KN63843, 22KV84681, 22KC81572, 22GE90257, 22KK76837, 22LP11522, 22KW71041, 22KC81576, 22LJ99657, 22KT78621, 22GL31211, 22KT78618, 22GL31212, 22GE90312, 22FZ11392, 22KE27576, 22KK75856, 22FZ11381, 22KK75857, 22LC26849, 22GL30413, 22LC26861, 22FZ11386, 22KK75882, 22GS19026, 22GL30433, 22FZ31393, 22FZ31384, 22LC22483, 22KK75834, 22GL30437, 22KN65901, 22KZ83472, 22FC34520, 22GS19086, 22LW65858, 22GL30499, 22FZ11388, 22KM14558, 22GS19041, 22GS19038, 22KK75887, 22FZ11399, 22KM14532, 22GS19047, 22GS19036, 22FC34547, 22GL30455, 22FC34533, 22FS41065, 22FZ11395, 22KE27510, 22KK75840, 22LW85855, 22KV84546, 22FX22926, 22KE27570, 22GS19074, 22KE27569, 22GS19060, 22KE27534, 22KE27588, 22FS41075, 22GL30404, 22GS19027, 22KV84549, 22KK75835, 22KK75827, 22FC34544, 22GL30454, 22FZ21383, 22KE27536, 22FZ21375, 22KE27561, 22KE27517, 22GL30402, 22KE27558, 22KZ33481, 22GS19058, 22GL30438, 22GS19045, 22FS41077, 22LJ69048, 22KE27532, 22KZ33470, 22GS19087, 22KC33129, 22FZ21365, 22FS41089, 22KC83128, 22KZ33475, 22GM00895, 22KV84551, 22KE27529, 22GL30422, 22LW85857, 22KE27593, 22LJ99035, 22KV84733, 22KC81571, 22KW71051, 22GE90279, 22LF11523, 22GL31177, 22GE90269, 22KW71061, 22KW71064, 22KC81579, 22KY84728, 22LF11535, 22KC81585, 22KC81575, 22GL31179, 22KC81585, 22KV84715, 22FX23337, 22KW71060, 22KW71066, 22KK76835, 22KW71054, 22GL31187, 22GE90281, 22KV34708, 22KW71068, 22GL31188, 22LJ69626, 22GL31184, 22GL31175, 22KV34694, 22KC81583, 22LP11520, 22KV84736, 22KC81566, 22GE90280, 22GL31148, 22LJ99641, 22LP11507, 22KV84727, 22KC81578, 22KM63840, 22KW71069, 22KV84732, 22GL31196, 22GM01359, 22GM01350, 22KN63820, 22GL31173, 22GL31203, 22KT78636, 22FX23352, 22GL31215, 22GL31216, 22KM66315, 22FC34922, 22KT78617, 22KT78626, 22KM66317, 22FS41397, 22GL31210, 22KT78627, 22FX23349, 22GL31209, 22GL30453, 22GL30457, 22FZ21382, 22GL30461, 22KK75859, 22GL30459, 22GS19021, 22FZ21368, 22FZ21379, 22GS19055, 22LJ99053, 22LC26659, 22KE27567, 22KK75871, 22GS19057, 22KE27589, 22GS19032, 22KE27581, 22KE27571, 22GS19042, 22KN83838, 22LJ99623, 22LP11544, 22KV84740, 22LP11538, 22LJ99647, 22KV84744, 22KN63837, 22LJ99654, 22GL31189, 22KC81563, 22GM01362, 22LC26901, 22LJ99550, 22LJ99617, 22KN63813, 22LJ99539, 22KW71058, 22GE90255, 22LJ99625, 22LJ99645, 22LP11541, 22GE90274, 22GE90283, 22FX23347, 22GE90291, 22FZ20096, 22LP11593, 22FC34927, 22GE90317, 22KX79622, 22LJ99679, 22FZ20084, 22LP11558, 22KX79651, 22GE90324, 22FX23354, 22KE28213, 22GE90290, 22FS41394, 22GM01371, 22FX23353, 22KK75877, 22KK75852, 22KE27544, 22FZ21364,22KK75846, 22FS41087, 22LW85669, 22LW85659, 22GM01361, 22LJ99644, 22GE90240, 22GL31194, 22GM01351, 22LJ99628, 22LJ99642, 22LJ99649, 22LJ99646, 22FZ20589, 22LJ99664, 22GE90303, 22LP11570, 22LP11572, 22KX79615, 22LP11556, 22FS41422, 22LJ99665, 22KX79639, 22LP11555, 22LJ99667, 22LJ99665, 22KX79637, 22LP11577, 22KN66318, 22FC34937, 22LJ99706, 22KN66312, 22FC34932, 22LJ99685, 22LP11566, 22FC34938, 22KZ63484, 22KZ63492, 22KE27564, 22GS19033, 22KK75882, 22FC34510, 22LW85656, 22LJ99662, 22KW71036, 22KK76834, 22FX23328, 22LP11504, 22KT78614, 22KN63810, 22KW71036, 22LJ99648, 22LJ99660, 22GE90288, 22GE90310, 22GE90307, 22KE28203, 22GM01382, 22GL30400, 22GL30448, 22GS19054, 22GS19056, 22FS41082, 22KN65905, 22KK75824, 22LC26648, 22FC34546, 22KZ83475, 22KE27550, 22FC34516, 22FC34535, 22KC83133, 22GE90272, 22KT78609, 22KW71048, 22LP11498, 22KE27583, 22KK75836, 22LJ99039, 22KE27573, 22LW56670, 22GL30408, 22KK75638, 22KE27608, 22LP11501, 22KV84686, 22LJ99629, 22KN63834, 22KV84742, 22FX23333, 22KN63808, 22FC34892, 22KX79652, 22FX23357, 22FQ33678, 22LJ99691, 22FZ20091, 22KX79644, 22KW70688, 22KV84528, 22KV84548, 22GL31205, 22GL31220, 22GE90318, 22KT78629, 22GE90325, 22KT78628, 22KE28212, 22KE28211, 22FZ20068, 22KT78624, 22LJ99688, 22LP11589, 22LJ99693, 22LJ99694, 22LW85660, 22KK75823, 22KK75820, 22LW85653, 22LW85654, 22LP11533, 22GL31186, 22GE90271, 22GM01348, 22KC81574, 22GE90277, 22LJ99632, 22LJ99630, 22GE90287, 22KT78607, 22KT78608, 22KC81580, 22LC26699, 22LP11526, 22LJ99635, 22KE28196, 22KC81592, 22GS19689, 22GS19693, 22GE90311, 22GE90297, 22KC81596, 22GS19694, 22GE90293, 22KX79628, 22GL30415, 22GS19050, 22GM00889, 22KE27560, 22KK75841, 22LC26657, 22LC26653, 22GL30405, 22GL30456, 22LJ99036, 22FZ21389, 22KE27598, 22GL30460, 22GS19052, 22LW85652
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters dated June 2, 2006. Firm initiated recall is ongoing.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
893 units
DISTRIBUTION
MD, NJ, PA, and PR

___________________________________
PRODUCT
Smiths Medical Fast Flow Fluid Warmer
- Level 1 H-1200 with H-30 and/or H-31B Fast Flow Fluid Warmer
- Level 1 H-30, H-31A and/or H-31B with Air Detector Clamp/Users,
Recall # B-1258-07
CODE
All units in distribution since September 2003.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by Safety Alert Notice dated February 22, 2007. Firm initiated recall is ongoing.
REASON
Fluid Warmers, with defective air detector clamping mechanisms which could cause air embolism, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,442 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Source Plasma, Recall # B-1259-07
CODE
Units: 0520309541, 0520309287, 0520308873, 0520308661, 0520308330, 0520307961, 0520306892, 0520306668, 0520305934, 0520305547, 0520305383, 0520304863, 0520304639, 0520304094, 0520303699 and 0520303473
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Memphis, TN, by facsimile on August 18, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0731-07
CODE
Units: LK00735 and LC37006
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during shipment, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

___________________________________
PRODUCT
Source Plasma, Recall # B-0852-07
CODE
Units: 05FIND9768, 05FINE0051, 05FINE0147, 05FINE1162, 05FINE1354, 05FINE1979, 05FINE1981, 05FINE2139, 05FINE2166, 05FINE3609, 05FINE3764, 05FINE3861, 05FINE4243, 05FINE4299, 05FINE4305, 05FINE4541, 06FINA0597, 06FINA1311, 06FINA2290, 05FINA2588, 06FINA2819, 06FINA3568, 06FINA5671, 06FINA6550, 06FINA7091, 06FINA7553, 06FINA8120, 06FINA8454, 06FINA8683, 06FINA8735, 06FINA8972, 06FINA9192, 06FINA9228, 06FINB0296, 06FINB0664, 06FINB0996, 06FINB1307, 06FINB1928, 06FINB2307, 06FINB2243, 06FINB2426, 06FINB2572, 06FINB2733, 06FINB2791, 06FINB3256, 06FINB3455, 06FINB3498, 06FINB4110, 06FINB4210, 06FINB4701, 06FINB5685, 06FINB6629, 06FINB6880, 06FINB6916, 06FINB7046, 06FINB7284, 06FINB7317, 06FINB8515, 06FINB8842, 06FINC0101, 06FINC0713, 06FINC0750, 06FINC1609, 06FINC1640, 06FINC1762, 06FINC1790, 06FINC2179, 06FINC2273, 06FINC2399, 06FINC2421, 06FINC3159, 06FINC3252, 06FINC3765, 06FINC3886, 06FINC4120, 05FINC5116, 06FINC5156, 06FINC5166, 06FINC5612, 06FINC5645, 06FINC5732, 06FINC5762, 06FINC5861, 06FINC6615, 06FINC6723, 06FINC7033, 06FINC7047, 06FINC7092, 06FINC8069, 06FINC8467, 06FINC9175, 06FINC9425, 06FINC9431, 06FINC9550, 06FINC9567, 06FIND0249, 06FIND0340, 06FIND0419, 06FIND0866, 06FIND1300, 06FIND1320, 06FIND1456, 06FIND1977, 06FIND2022, 06FIND2539, 06FIND2628, 06FIND8069
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fort Wayne, IN, by fax on December 19, 2006. 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
107 units
DISTRIBUTION
CA and France

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0915-07
CODE
Unit: 026FF59466
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on September 20, 2005 and by letter dated September 30, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0916-07
CODE
Units: 41FQ10756 (2 units), 41FT88740 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on May 3, 2006 and by letter dated May 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL

___________________________________
PRODUCT
Source Plasma, Recall # B-1049-07
CODE
Units: 0060030072, 0060029752, 0060029613, 0060029290, 0060029109, 0060028745, 0060028614, 0060028319, 0060028135, 0060027847, 0060027677, 0060027416, 0060027300, 0060026993, 0060026897, 0060026456, 0060026179, 0060026041, 0060025806, 0060025671, 0060025363, 0060025202, 0060024986, 0060024802, 0060024581, 0060024447, 0060024243, 0060024121, 0060023425, 0060023239, 0060023047, 0060022947, 0060022664, 0060022637, 0060022385, 0060022321, 0060022095, 0060021987, 0060021752, 0060021701, 0060021465, 0060021431, 0060021218, 0060021159, 0060020981, 0060020937, 0060020804, 0060020777, 0060020695, 0060020659, 0060020580, 0060020554, 0060020477, 0060020306, 0060020239, 0060020186, 0060020083, 0060019388, 0060017754, 0060017596, 0060017154, 0060016312, 0060016011, 0060015379, 0060014884, 0060014704, 0060014253, 0060014110, 0060013312, 0060012894, 0060011973, 0060011850, 0060011488, 0060010710, 0060010184, 0060009498, 0060009396, 0060008770, 0060008482, 0060008176, 0060007903, 0060007400, 0060006501, 0060005290, 0060005064, 0060004717, 0060004521, 0060003682, and 0060003515
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., City of Industry, CA, by facsimile dated June 8, 2005.
Manufacturer: Biomat USA, Inc., Boise, ID. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was previously deferred for testing reactive for Hepatitis B surface antigen (HBsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
Source Plasma, Recall # B-1215-07
CODE
Units: I72058064, 364007007, 364007740, 364009976, 364010716, and 364011858
RECALLING FIRM/MANUFACTURER
International BioResources, L.L.C, dba Talecris Plasma Resources, Fort Worth, TX, by facsimile on November 29, 2006. 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
6 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1216-07
CODE
Units: 172055088 and 364010411
RECALLING FIRM/MANUFACTURER
International BioResources, L.L.C, dba Talecris Plasma Resources, Fort Worth, TX, by facsimile on November 27, 2006. 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
2 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1217-07
CODE
Units: 172059090, 172059548, and 364013331
RECALLING FIRM/MANUFACTURER
International BioResources, L.L.C, dba Talecris Plasma Resources, Fort Worth, TX, by facsimile on November 30, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

___________________________________
PRODUCT
a) Red Blood Cells, Recall B-1236-07;
b) Platelets Pooled, Recall # B-1237-07
CODE
a) Unit: KQ55908;
b) Units: (3 pooled units) P26695 (KQ55878, KQ55879, KQ55880, KQ55904),
P26698 (KQ55890, KQ55891, KQ55892, KQ55894, KQ55896, KQ55907) and
P26717 (KQ55895, KQ55893, KQ55897, KQ55898, KQ55900, KQ55905)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on July 14, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WI

___________________________________
PRODUCT
Red Blood Cells, Recall # B-1250-07
CODE
Unit: 041FS25437
RECALLING FIRM/MANUFACTURER
American National Red Cross, Alabama Region, Birmingham, AL, by telephone on March 14, 2006 and by letter dated March 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1253-07
CODE
Units: LC39515, LC39519, LC39522, LC39541
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile dated September 18, 2003. Firm initiated recall is complete.
REASON
Platelets, with quality control performed using expired controls, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
Conditional Fiber Optic Laryngoscope Kit, which contains laryngoscope blades, handles and 2 battery packs for use in Magnetic Resonance environments; catalog number 005852300, Recall # Z-0758-2007
CODE
Battery lot numbers: 065201-065228, 065231, 065232, 065233
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by telephone and letter on March 1, 2007.
Manufacturer: Truphatek, Ltd., Netanya, Israel. Firm initiated recall is complete.
REASON
The MRI Battery is out of specification for its magnetic content.
VOLUME OF PRODUCT IN COMMERCE
1 kit
DISTRIBUTION
GA

___________________________________
PRODUCT
83 plus Mini-flex with accessory crate, Automatic Endoscope Reprocessor (AER) to clean and high level disinfect ENT/Bronch/Urology scopes between patient usage, Recall # Z-0770-2007
CODE
Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
RECALLING FIRM/MANUFACTURER
Custom Ultrasonics, Ivyland,PA, by telephone and letters on December 12, 2005. Firm initiated recall is ongoing.
REASON
The device was marketed without a 510k.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, GA, VA, and UK

___________________________________
PRODUCT
Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007
CODE
Serial #: A1A0642100; A1A0642102; A1B0662183; A1B0662184; A1B0662256; A1B0662257; A1B0662258; A1B0662327; A1B0662328; A1B0662330; A1B0662331; A3A0652115; A3B0662284; A3B0662285; A3B0662286; A3B0662287; A3B0662288; A3B0662289; A3B0662290; A3B0662291; A3B0662292; A3B0662293; A3B0662371; A3B0662372; A3B0662373; A3B0662374; A3B0662375; A3B0662376; A3B0662377; A3B0662378; A3B0662379; A3B0662380; A3B0672415; A3B0672416; A3B0672417; A3B0672418; A3B0672419
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on December 19, 2006.
Manufacturer: Toshiba Medical Systems Corp., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Lumex® Walkabout Lite Four-Wheel Rollator, Recall # Z-0772-2007
CODE
Model numbers: RJ4300B, RJ4300D, RF4300G, RJ4300K, RJ4300R, and Imperial model RF4400K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Graham-Field, Inc., Bay Shore,NY, by letter on April 3, 2007.
Manufacturer: Dan Yang Ju Mad Healthcare Equipment Co., Ltd., Jietpai Town, Dan Yang, Jiangsu, China. Firm initiated recall is ongoing.
REASON
The caster bolt stem/screw may loosen over time causing the wheel to come off.
VOLUME OF PRODUCT IN COMMERCE
13,300 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) BacT/ALERT Classic System Software, Blood Culturing System,
Recall # Z-0773-2007;
b) BacT/ALERT 3D System Software, Blood Culturing System,
Recall # Z-0774-2007;
c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System,
Recall # Z-0775-2007;
d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System,
Recall # Z-0776-2007
CODE
All Models
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on/about October 18, 2006 and October 31, 2006. Firm initiated recall is ongoing.
REASON
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
VOLUME OF PRODUCT IN COMMERCE
10,790 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007
CODE
Serial numbers prior to 07020343 with Software versions prior to V1.1.3
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Lexington, MA, by Service Reps and e-mail on March 21 and March 27, 2007. Firm initiated recall is ongoing.
REASON
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result.
VOLUME OF PRODUCT IN COMMERCE
210 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic, Recall # Z-0779-2007
CODE
Lot Number: 061212 , Exp 2008-12-22 Lot Number: 061020, Exp 2008-10-20
RECALLING FIRM/MANUFACTURER
American Diagnostica, Inc., Stamford,CT, by letter and e-mail on February 28, 2007. Firm initiated recall is ongoing.
REASON
Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas.
VOLUME OF PRODUCT IN COMMERCE
96 kits
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI's Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery, Recall # Z-0780-2007
CODE
Listing 878.4950
RECALLING FIRM/MANUFACTURER
Orthopedic Systems Inc., Union City,CA, by letter on February 16, 2007. Firm initiated recall is ongoing.
REASON
Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.
VOLUME OF PRODUCT IN COMMERCE
8 devices
DISTRIBUTION
ID, IL, NY, and CA

___________________________________
PRODUCT
B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets, Recall # Z-0783-2007
CODE
Lot number 0060911602
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown,PA, by letter on April 11, 2007.
Manufacturer: B Braun of Puerto Rico, Inc., Sabana Grande,PR. Firm initiated recall is ongoing.
REASON
The integrity of the sterile product barrier may be compromised.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
a) SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1;
Made in France; Recall # Z-0781-2007;
b) SOPRO Camera Control Units, PAL, SV420P, REF (Catalog) #72200506 v1.1;
Made in France, Recall # Z-0782-2007
CODE
a) Serial #’s: BE, 420-8161, 420-8013, 420-8026, 420-8056, 420-8041, 420-8134,
420-8137, 420-8059, 420-8135, 420-8010, 420-8014, 420-8132, 420-8018,
420-8020, 420-8035, 420-8045, 420-8114, 420-8115, 420-8136, 420-8140,
420-8143, 420-8146, 420-8149, 420-8155, 420-8113, 420-8142, 420-8151,
420-8154, 420-8058, 420-8050, 420-8033, 420-8138, 420-8038, 420-8054,
420-8036, 420-8037, 420-8043, 420-8133, 420-8025, 420-8015, 420-8019,
420-8028, 420-8030, 420-8031, 420-8032, 420-8042, 420-8049, 420-8057,
420-8039, 420-8119, 420-8120, 420-8040, 420-8118, 420-8145, 420-8152,
420-8046, 420-8011, 420-8055, 420-8141, 420-8021, 420-8112, 420-8024,
420-8048, 420-8144, 420-8016, 420-8017, 420-8022, 420-8023, 420-8047,
420-8052, 420-8044, 420-8034, 420-8053, 420-8029, 420-8051, 420-8058;
b) Serial #’s: 420-8283, 420-8275, 420-8285, 420-9006, 420-8271, 420-8277,
420-8289, 420-9015, 420-9000, 420-9001, 420-9002, 420-9004, 420-9005,
420-9007, 420-9008, 420-9009, 420-9010, 420-9012, 420-9014, 420-9016,
420-9017, 420-9018, 420-9019, 420-8282 and 420-9013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc Endoscopy Division, Oklahoma City,OK, by letter and telephone on January 19, 2007.
Manufacturer: Sopro Zac Athelia IV, La Ciotat Cedex, France. Firm initiated recall is ongoing.
REASON
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
VOLUME OF PRODUCT IN COMMERCE
102 units
DISTRIBUTION
Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

___________________________________
PRODUCT
Fort Dodge Cydectin, moxidectin, Injectable Solution for Beef and Nonlactating Dairy Cattle, Antiparasitic, Sterile, packaged in 200- and 500-ml. bottles, containing 10 mg. moxidectin/ml, OTC, NADA 141-220, NDC 0856-4930-02 (200 ml) and NDC 0856-4930-03 (500 ml), Recall # V-033-2007
CODE
493103 30-Nov-07; 493104 30-Nov-07; 493109 30-Nov-07; 493110 30-Nov-07; 493111 31-Dec-07; 493112 31-Dec-07; 493113 31-Dec-07; 493115 31-Dec-07; 493116 31-Jan-08; 493117 31-Dec-07; 493118 31-Dec-07; 493119 31-Jan-08; 493120 31-Jan-08; 493122 31-Jan-08; 493123 31-Jan-08; 493124 31-Jan-08; 493125 31-Jan-08; 493126 31-Jan-08; 493127 31-Jan-08; 493128 31-Jan-08; 493129 31-Jan-08; 493130 31-Jan-08; 493131 31-Jan-08; 493132 31-Mar-08; 493133 31-Mar-08; 493134 31-Mar-08; 493135 31-Mar-08; 493136 31-Mar-08; 493137 31-Mar-08; 493138 30-Apr-08; 493139 30-Apr-08; 493140 30-Apr-08; 493141 31-Mar-08; 493142 30-Apr-08; 493143 30-Apr-08; 493144 30-Apr-08; 493145 30-Apr-08; 493146 30-Apr-08; 493148 30-Apr-08; 493149 30-Apr-08; 493150 30-Apr-08; 493151 30-Apr-08; 493152 30-Apr-08; 493154 30-Apr-08; 493155 30-Apr-08; 493156 30-Apr-08; 493157 30-Jun-08; 493158 30-Jun-08; 493160 30-Jun-08; 493161 31-Jul-08; 493162 31-Jul-08; 493163 31-Jul-08; 493164 31-Jul-08; 493165 31-Aug-08; 493166 31-Aug-08; 493167 31-Aug-08; 493168 31-Aug-08; 493169 31-Aug-08; 493170 31-Aug-08; 493171 30-Sep-08; 493172 30-Sep-08; 493173 30-Sep-08; 493174 30-Sep-08; 493175 30-Sep-08; 493176 30-Sep-08; 493177 30-Sep-08; 493178 30-Sep-08; 493179 30-Sep-08; 493180 30-Sep-08; 493181 30-Sep-08; 493182 31-Oct-08; 493183 31-Oct-08; 493184 31-Oct-08; 493185 31-Oct-08
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated March 16, 2007. Firm initiated recall is ongoing.
REASON
Firm cannot assure validated parameters were met in the aseptic filing room.
VOLUME OF PRODUCT IN COMMERCE
7,476/200-ml. Bottles and 44,365/500-ml. bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Fort Dodge Aureomycin Chlortetracycline Soluble Powder, For Veterinary Use in Drinking Water, containing 25 g/lb. chlortetracycline HCl, packaged in 6.4-oz. pouches, 62 pouches per pail, NADA 65-071, Recall # V-034-2007
CODE
Lot 060310, Exp. February, 2009
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated March 2, 2007. Firm initiated recall is ongoing.
REASON
9-month stability sample was out of specification (low) for chlortetracycline HCI.
VOLUME OF PRODUCT IN COMMERCE
139/62-pouch pails
DISTRIBUTION
Nationwide and Panama

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

___________________________________
PRODUCT
Bulk LVO Starter IV CSP Pellet Medicated, A Complete Starter Feed for Baby Pigs, containing 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton penicillin (as procaine), 7-day withdrawal period, Recall # V-035-2007
CODE
Requisition (batch) 38753, 38812, 38894, 38955, and 39055
RECALLING FIRM/MANUFACTURER
Recalling Firm: MFA, Inc., Columbia, MO, by telephone on April 11, 2007.
Manufacturer: MFA Feed Mill, Inc., Centralia, MO. Firm initiated recall is complete.
REASON
The product is mislabeled as containing sulfathiazole, but it actually contains sulfamethazine.
VOLUME OF PRODUCT IN COMMERCE
131 tons bulk feed
DISTRIBUTION
MO

___________________________________
PRODUCT
Bulk LVO Starter IV CSP Pellet Medicated, A Complete Starter Feed for Baby Pigs, containing 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton penicillin (as procaine), 7-day withdrawal period, Recall # V-036-2007
CODE
Requisition (batch) 38673
RECALLING FIRM/MANUFACTURER
Recalling Firm: MFA, Inc., Columbia, MO, by telephone on April 10, 2007.
Manufacturer: MFA Feed Mill, Inc., Centralia, MO. Firm initiated recall is complete.
REASON
The product was supposed to only contain AureoZol containing sulfathiazole, but Aureomix containing sulfamethazine was also used
VOLUME OF PRODUCT IN COMMERCE
33.7 tons bulk feed
DISTRIBUTION
MO

END OF ENFORCEMENT REPORT FOR MAY 9, 2007

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