November 27, 2002
02-47
PRODUCT
Robinul Forte Tablets (glycopyrrolate tablets USP) 2mg, physician sample cartons of 8 tablets (2 cards @4 tablets per card), Rx only. Recall # D-058-3.
CODE
Lot Number H020572.
RECALLING FIRM/MANUFACTURER
Recalling Firm: First Horizon Pharmaceutical Corp., Alpharetta, GA, by letters dated September 6, 2002.
Manufacturer: Mikart, Inc., Pharmaceutical Manufacturers, Atlanta, GA. Firm initiated recall is ongoing.
REASON
Product contains glass particles.
VOLUME OF PRODUCT IN COMMERCE
386 cartons (8 tablets each/2 blister cards of 4 tablets per card).
DISTRIBUTION
Nationwide.
PRODUCT
Etodolac Extended-Release Tablets, 500 mg, 100 count bottles, Rx only. Recall # D-059-3.
CODE
Lot number 502044 exp. 2/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA Inc., North Wales, PA, by letters dated October 23, 2002.
Manufacturer: Teva Pharmaceuticals USA Inc., Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Tablet mixup; a bottle labeled to contain Etodolac Extended-Release tablets was found to contain both Etodolac Extended-Release tablets and one tablet of Tramadol HCl 50 mg
VOLUME OF PRODUCT IN COMMERCE
4084 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
a) R-Tanna S Pediatric Suspension (Chlorpheniramine
Tannate 4.5mg and Phenylephrine tannate 5 mg) 4 fl oz (118mL) bottles, Rx only. Recall # D-055-3;
b) CP-Tannic Suspension (Chlorpheniramine tannate 4.5mg
and Phenylephrine tannate 75mg) 4fl oz (118mL) and 16fl oz (473mL) bottles, Rx only. Recall # D-056-3.
CODE
a) Lot# GB024;
b) Lot# GA984, GA986, GB005, GB033 and GB036.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kiel Laboratories, Inc., Gainesville, GA, by fax on/about September 12, 2002. Firm initiated recall is ongoing.
REASON
SUBPOTENT; R-Tanna S Pediatric Suspension for phenylephrine tannate (3 month stability); CP-Tannic Suspension for chlorpheniramine tannate ( 1 month stability).
VOLUME OF PRODUCT IN COMMERCE
a) 5463 bottles;
b) 12817 bottles.
DISTRIBUTION
OH and MS.
PRODUCT
Rhinocort Nasal Inhaler (budesonide) 7 g, 200 Metered Doses, For Nasal Inhalation with Rhinocort Adaptor Only, Rx only. Recall # D-060-3.
CODE
Lot Number: CH300;
Exp. Date: February 28,2003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca, Wilmington, DE, by letter on November 6, 2002.
Manufacturer: 3m Health Care, Ltd,. Leicestershire, England. Firm initiated recall is ongoing.
REASON
Defective container; inhaler may not consistently deliver acceptable spray after the initial spray
VOLUME OF PRODUCT IN COMMERCE
90,540 units.
DISTRIBUTION
Nationwide.
PRODUCT
Red Blood Cells, Recall # B-0119-3.
CODE
Unit L80470.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated July 8, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose hematocrit or hemoglobin were not determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
PRODUCT
a) Blood Cells, Leukoreduced, Irradiated,
Recall # B-0121-3.
b) Blood Cells, Leukoreduced, Recall # B-0122-3.
CODE
a) Unit 0664306;
b) Unit 0664309.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Center of the Pacific, San Francisco, CA, by letter dated August 13, 2001.
Manufacturer: Blood Centers of the Pacific, Peninsula/South Bay Center, Burlingame, CA.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to incorrect documentation of the hemoglobin/hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Frozen, Recall # B-0129-3.
CODE
Unit 1711114.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter dated October 21, 1998. Firm initiated recall is complete.
REASON
Frozen Red Blood Cells, deglycerolized using expired 1.6% sodium chloride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.
PRODUCT
Red Blood Cells, Recall # B-0130-3.
CODE
Unit FH94107.
RECALLING FIRM/MANUFACTURER
Alton Ochsner Medical Foundation Blood Bank, New Orleans, LA, by telephone on October 10, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of skin piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0167-3.
CODE
Unit 27LM11416.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter dated December 12, 2001.
Firm initiated recall is complete.
REASON
Platelets, manufactured with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0168-3.
CODE
Unit 27LX05784.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by telephone on June 4, 2001.
Firm initiated recall is complete.
REASON
Blood product, which tested non-reactive for antibody to the hepatitis B core antigen (anti-Hbcore), but was collected from a donor who previously tested reactive on two prior occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0169-3;
b) Platelets, Recall # B-0170-3;
c) Recovered Plasma, Recall # B-0171-3.
CODE
a); b) and c) Unit 27LY00661.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter dated August 22, 2001 and by telephone on August 27, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post-donation information related to their spouse testing repeatedly reactive for anti-HBcore and anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WV and NY.
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0172-3.
CODE
Unit 27GG15664.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter dated January 7, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected in a manner that compromises the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-0173-3.
b) Platelets, Irradiated, Recall # B-0174-3.
CODE
a) Units 27LR15786, 27GX40206;
b) Units 27LR11331, 27LX04718, 27LR11343, 27LR11346.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter dated February 26, 2002, 2002. Firm initiated recall is complete.
REASON
Blood products, which lacked documentation of irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
WV and OH.
____________________________
PRODUCT
Red Blood Cells Leukocytes Removed Irradiated, Recall # B-0211-3.
CODE
Unit 40FE74229.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America Region, Peoria, IL, by telephone on August 15, 2002. Firm initiated recall is complete.
REASON
Blood product, which contained anti-D antibodies, but was labeled as negative for anti-D, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells Leukocytes Removed Irradiated, Recall # B-0212-3.
CODE
Units 40GC66417 and 40GH48259.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Heart of America Region, Peoria, IL, by letters dated August 13 and September 25, 2002. 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
IL and MI.
PRODUCT
Red Blood Cells, Recall # B-0213-3.
CODE
Unit E07593.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated April 9, 2002. 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
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0216-3.
CODE
Unit 27LX01013.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by telephone on July 24, 2000.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had recently had thallium stress test performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.
PRODUCT
Source Plasma, Recall # B-0218-3.
CODE
Units 58FWBXPF0, 58FWBXTN0, 58FWBYBP0, 58FWBYDL0, 58FWBYHL0, and 58FWBYKX0.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Bloomington, IL, by fax on July 31, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken illegal drugs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.
PRODUCT
Platelets, Recall # B-0219-3.
CODE
Unit 261700546.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on October 20, 2001. Firm initiated recall is complete.
REASON
Blood product, which was not tested for the antibody to the cytomegalovirus (CMV) but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-222-3;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0223-3.
CODE
a) Unit numbers 15387-4333 and 15390-2845;
b) Unit numbers 15388-7250 and 15388-9475.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letter on March 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0224-3;
b) Platelets, Recall # B-0225-3.
CODE
a) Unit numbers 26161-4446 and 26166-6255;
b) Unit number 26166-6255.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by letter on July 24, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells, Recall # B-0226-3.
CODE
Unit numbers 26165-9051 and 26166-8270.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by letter dated July 17, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells Pheresis, Recall # B-0228-3.
CODE
Units E24130, E40775, E41461, E81148 (Parts 1 and 2), E58323, E54261, E64005, E56141, E65352, E40780, and E36614.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letters dated September 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for hematocrit and red cell volume as part of quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells Leukocytes Removed, Recall # B-0229-3.
CODE
Unit 261674075.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Forth Smith, AR, by telephone on June 5, 2001. Firm initiated recall is complete.
REASON
Blood product, which was positive for the antibodies to the cytomegalovirus (CMV) but was labeled as non-reactive for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
Source Plasma, Recall # B-0233-3.
CODE
Unit numbers VP-34038 and VP-34061.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter on August 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Austria.
PRODUCT
a) Red Blood Cells, Recall # B-0235-3;
b) Red Blood Cells Irradiated, Recall # B-0236-3;
c) Red Blood Cells Leukocytes Removed, Recall # B-0237-3;
d) Red Blood Cells Leukocytes Removed Irradiated,
Recall # B-0238-3;
e) Platelets, Recall # B-0239-3
f) Fresh Frozen Plasma, Recall # B-0240-3
g) Recovered Plasma, Recall # B-0241-3.
CODE
a) Units 163569468, 163553014, 163553536, 163553342,
163553337, 163553319, and 163553091;
b) Unit 163581912;
c) Units 163571233, 163585605, 163585602, 163585571,
163585557, 163585503, 163585495, 163585444, 163585435,
163585434, 163585431, 163585421, 163585414, 163585407,
163582268, 163582266, 163582264, 163582130, 163582129,
163582126, 163582124, 163581955, 163581953, 163581946,
163581940, 163581937, 163581934, 163581931, 163581930,
163581929, 163581924, 163581920, 163581919, 163581918,
163581917, 163581916, 163581915, 163581914, 163581911,
163581910, 163581907, 163581906, 163581905, 163581904,
163581903, 163581901, 163581898, 163581775, 163581774,
163581771, 163581765, 163581761, 163581760, 163581759,
163581758, 163581757, 163581756, 163581755, 163581754,
163581751, 163581749, 163581748, 163581747, 163581746,
163581745, 163581744, 163581743, 163581740, 163581734,
163581733, 163581731, 163581728, 163581727, 163581726,
163581725, 163581724, 163581723, 163581722, 163581720,
163581719, 163581716, 163575794, 163575795, 163575797,
163575798, 163575800, 163575906, 163576140, 163576145,
163576147, 163576151, 163576152, 163577090, 163577843,
163577844, 163577851, 163577861, 163577867, 163577870,
163577875, 163577877, 163577878, 163577882, 163577885,
163578014, 163578017, 163578019, 163578021, 163578026,
163578027, 163578028, 163578030, 163578031, 163578039,
163578042, 163578043, 163578045, 163578055, 163578060,
163578061, 163578066, 163578067, 163578079, 163578080,
163578082, 163581699, 163581706, 163581707, 163581715,
163575793, 163575792, 163575791, 163575790, 163575789,
163575787, 163575786, 163575785, 163575784, 163575705,
163575637, 163575634, 163575633, 163575629, 163575628,
163575616, 163575451, 163574422, 163571279, 163571272,
163571251, 163571247, 163571243, 163571238, 163571208,
163571207, 163571202, 163571194, 163571189, 163571188,
163571187, 163571186, 163571185, 163571184, 163571123,
163571112, 163571075, 163571070, 163571068, 163571049,
163571035, 163571033, 163571029, 163571025, 163571023,
163571020, 163571017, 163571015, 163570995, 163570981,
163570976, 163570967, 163570947, 163570943, 163570940,
163570917, 163570913, 163570906, 163570904, 163570902,
163570886, 163570880, 163570798, 163570793, 163570790,
163570651, 163570629, 163570622, 163570619, 163570617,
163570616, 163570614, 163570613, 163570467, 163570463,
163570462, 163570440, 163570439, 163570335, 163570333,
163570329, 163570328, 163570326, 163570705, 163570706,
163570710, 163570712, 163570717, 163570723, 163570728,
163570732, 163570735, 163570736, 163570738, 163570739,
163570745, 163570747, 163570748, 163570325, 163570304,
163570301, 163570300, 163570299, 163570298, 163570297,
163570198, 163570195, 163570192, 163570191, 163570190,
163570180, 163570175, 163570166, 163570163, 163570161,
163570158, 163570156, 163570155, 163570152, 163570095,
163570085, 163570084, 163570083, 163570084, 163570080,
163570073, 163570072, 163570068, 163570067, 163570066,
163570063, 163570062, 163570056, 163570041, 163570039,
163570038, 163570037, 163570036, 163570035, 163570034,
163570033 , 163570030, 163570029, 163570027, 163570025,
163570024, 163570023, 163570022, 163570021, 163570020,
163570019, 163570018, 163570017, 163570016, 163570015,
163570014, 163570013, 163570012, 163570010, 163570009,
163570008, 163570007, 163569963, 163569960, 163569959,
163569958, 163569957, 163569955, 163569952, 163569951,
163569950, 163569948, 163569947, 163569946, 163569945,
163569943, 163569942, 163569940, 163569939, 163569938,
163569935, 163569933, 163569881, 163569875, 163569589,
163569588, 163569587, 163569586, 163569585, 163569583,
163569582, 163569580, 163569560, 163569546, 163569545,
163569543, 163569542, 163569540, 163569537, 163569536,
163569534, 163569533, 163569532, 163569530, 163569527,
163569523, 163569521, 163569519, 163569516, 163569515,
163569514, 163569511, 163569485, 163569482, 163569481,
163569479, 163569478, 163569476, 163569470, 163569467,
163565711, 163555000, 163554958, 163554957, 163554943,
163554942, 163554871, 163554870, 163554868, 163554867,
163554866, 163554863, 163554862, 163554861, 163554860,
163554858, 163554857, 163554854, 163554853, 163554851,
163554820, 163554849, 163554847, 163554846, 163554843,
163554840, 163554839, 163554834, 163554833, 163554832,
163554831, 163554827, 163554826, 163554825, 163554824,
163554823, 163554822, 163554818, 163554816, 163554814,
163554808, 163554807, 163554806, 163554803, 163554802,
163554801, 163554780, 163554777, 163554776, 163554775,
163554774, 163554773, 163554772, 163554771, 163554770,
163554769, 163554768, 163554766, 163554765, 163554763,
163554762, 163554761, 163554759, 163554758, 163554729,
163554728, 163554726, 163554725, 163554721, 163554719,
163554716, 163554711, 163554709, 163554707, 163554704,
163554702, 163554700, 163554699, 163554695, 163554694,
163554691, 163554690, 163554689, 163554688, 163554686,
163554685, 163554684, 163554683, 163554682, 163554681,
163554680, 163554679, 163554677, 163554675, 163554673,
163554670, 163554668, 163554665, 163554664, 163554662,
163554661, 163554658, 163554656, 163554398, 163554396,
163554394, 163554392, 163554388, 163554387, 163554386,
163554385, 163554384, 163554683, 163554380, 163554379,
163554378, 163554374, 163554369, 163554367, 163554355,
163554354, 163554331, 163554330, 163554200, 163554198,
163554197, 163554195, 163554194, 163554193, 163554192,
163554191, 163554190, 163554188, 163554186, 163554185,
163554183, 163554182, 163554120, 163554118, 163554108,
163554106, 163554105, 163554103, 163554102, 163554101,
163554087, 163553809, 163553808, 163553807, 163553799,
163553796, 163553795, 163553794, 163553793, 163553791,
163553787, 163553764, 163553755, 163553753, 163553749,
163553748, 163553747, 163553746, 163553743, 163553742,
163553741, 163553740, 163553739, 163553738, 163553737,
163553736, 163553735, 163553733, 163553731, 163553730,
163553728, 163553725, 163553724, 163553722, 163553721,
163553719, 163553718, 163553713, 163553708, 163553707,
163553706, 163553590, 163553588, 163553586, 163553540,
163553539, 163553538, 163553537, 163553488, 163553487,
163553484, 163553482, 163553481, 163553480, 163553475,
163553444, 163553441, 163553440, 163553438, 163553434,
163553421, 163553419, 163553418, 163553411, 163553409,
163553408, 163553407, 163553406, 163553395, 163553382,
163553381, 163553378, 163553376, 163553370, 163553367,
163553366, 163553364, 163553362, 163553359, 163553354,
163553353, 163553346, 163553344, 163553339, 163553333,
163553332, 163553331, 163553330, 163553325, 163553323,
163553321, 163553318, 163553317, 163553316, 163553315,
163553313, 163553311, 163553309, 163553308, 163553306,
163553305, 163553303, 163553302, 163553301, 163553300,
163553297, 163553296, 163553199, 163553198, 163553195,
163553194, 163553191, 163553190, 163553189, 163553188,
163553187, 163553186, 163553185, 163553183, 163553182,
163553181, 163553180, 163553179, 163553178, 163553177,
163553176, 163553175, 163553098, 163553097, 163553095,
163553094, 163553092, 163553089, 163553088, 163553087,
163553086, 163553085, 163553084, 163553083, 163553082,
163553080, 163553038, 163553033, 163553028, 163553022,
163553021, 163553020, 163553016, 163553015, 163553011,
163553010, 163553009, 163553008, 163553007, 163553006,
163553005, 163553004, 163553003, 163553001, 163553000,
163552999, 163552974, 163552973, 163552972, 163552969,
163552967, 163552965, 163552960, 163552959, 163552958,
163552955, 163552953, 163552950, 163552947, 163552946,
163552942, 163552941, 163552727, 163552724, 163552400,
163552398, 163552335, 163552329, 163552319, 163552318,
163552717, 163581922, 163553081, and 163552728;
d) 163553535 and 163570749;
e) 163585519, 163585503, 163585496, 163585495, 163585456,
163585444, 163585435, 163585434, 163585431, 163585424,
163581775, 163581771, 163581765, 163575794, 163575795,
163575798, 163576140, 163576151, 163576152, 163577861,
163577867, 163577870, 163578055, 163575792, 163575791,
163575790, 163575786, 163575785, 163575634, 163575633,
163575629, 163575616, 163571243, 163571233, 163571075,
163571068, 163570981, 163570967, 163570335, 163570333,
163570329, 163570328, 163570326, 163570705, 163570710,
163570712, 163570723, 163570728, 163570732, 163570736,
163570738, 163570745, 163570747, 163570748, 163570749,
163570325, 163570304, 163570301, 163570300, 163570299,
163570298, 163570297, 163570195, 163570192, 163570191,
163570163, 163570161, 163570156, 163570155, 163570152,
163554871, 163554870, 163554868, 163554867, 163554866,
163554863, 163554862, 163554858, 163554857, 163554853,
163554850, 163554847, 163554846, 163554843, 163554824,
163554803, 163554802, 163554388, 163554387, 163554386,
163554385, 163554383, 163554380, 163554379, 163554378,
163554355, 163554354, 163554198, 163554195, 163554192,
163554191, 163554087, 163553809, 163553808, 163553807,
163553799, 163553795, 163553791, 163553787, 163553539,
163553537, 163553488, 163553487, 163553484, 163553480,
163553411, 163553409, 163553407, 163553406, 163553330,
163553316, 163553306, 163553305, 163553303, 163553302,
163553297, 163553038, 163553011, 163553010, 163553009,
163553008, 163553007, 163553006, 163553000, and
163552398;
f) Units 163575800, 163575787, 163574422, 163570629,
163570622, 163570620, 163570619, 163570617, 163570614,
163570728, 163570736, 163570304, 163570301, 163570195,
163570166, 163570161, 163570158, 163570155, 163553791,
163553787, 163553539, 163553538, 163553537, 163553487,
163553475, 163553330, 163553325, 163553321, 163553319,
163553318, 163553317, 163553316, 163553313, 163553311,
163553309, 163553308, 163553306, 163553305, 163553303,
163553302, 163553300, 163553297, 163553296, 163553199,
163553198, and 163553195;
g) Units 163554330, 163581761, 163581759, 163581758,
163581757, 163581755, 163581754, 163581751, 163581750,
163581749, 163581748, 163581747, 163581746, 163581745,
163581744, 163581743, 163581740, 163577843, 163577844,
163577851, 163577875, 163577877, 163577878, 163577882,
163578014, 163578017, 163578021, 163578039, 163578042,
163578043, 163578045, 163578060, 163578061, 163578066,
163578067, 163578079, 163578082, 163581699, 163581706,
163581707, 163575705, 163571279, 163571251, 163571247,
163571238, 163571194, 163571184, 163571123, 163571112,
163571049, 163571035, 163571033, 163571029, 163571025,
163571023, 163571020, 163571017, 163571015, 163571008,
163570995, 163570976, 163570947, 163570943, 163570940,
163570917, 163570913, 163570906, 163570904, 163570886,
163570880, 163570651, 163570467, 163570463, 163570462,
163570440, 163570439, 163570717, 163570293, 163570180,
163570175, 163570095, 163570085, 163570084, 163570083,
163570081, 163570080, 163570076, 163570072, 163570068,
163570067, 163570066, 163570063, 163570062, 163570056,
163570033, 163570030, 163570027, 163570025, 163570024,
163570023, 163570022, 163570021, 163570020, 163570019
163570013, 163570012, 163570010, 163570009, 163570008,
163570007, 163569881, 163569875, 163569543, 163569542,
163569540, 163569537, 163569536, 163569534, 163569533,
163569532, 163569530, 163569527, 163569521, 163569519,
163569516, 163569515, 163569514, 163569482, 163565711,
163555000, 163554958, 163554943, 163554942, 163554861,
163554854, 163554851, 163554849, 163554840, 163554839,
163554834, 163554833, 163554832, 163554831, 163554827,
163554822, 163554821, 163554780, 163554777, 163554776,
163554775, 163554774, 163554773, 163554772, 163554771,
163554770, 163554769, 163554768, 163554766, 163554765,
163554763, 163554762, 163554761, 163554759, 163554758,
163554729, 163554728, 163554726, 163554725, 163554721,
163554720, 163554719, 163554716, 163554711, 163554709,
163554707, 163554704, 163554702, 163554700, 163554699,
163554695, 163554694, 163554691, 163554690, 163554689,
163554688, 163554686, 163554685, 163554684, 163554682,
163554681, 163554680, 163554679, 163554677, 163554675,
163554673, 163554670, 163554668, 163554665, 163554664,
163554662, 163554661, 163554658, 163554656, 163554398,
163554396, 163554394, 163554392, 163554331, 163554186,
163554185, 163554183, 163554182, 163554120, 163554108,
163554106, 163554105, 163554104, 163554103, 163554094,
163554090, 163554088, 163553764, 163553755, 163553753,
163553749, 163553747, 163553746, 163553743, 163553742,
163553741, 163553740, 163553739, 163553738, 163553737,
163553736, 163553735, 163553733, 163553731, 163553730,
163553728, 163553725, 163553724, 163553722, 163553721,
163553719, 163553718, 163553713, 163553707, 163553706,
163553590, 163553588, 163553586, 163553540, 163553535,
163553434, 163553421, 163553419, 163553418, 163553408,
163553395, 163553382, 163553381, 163553378, 163553376,
163553370, 163553367, 163553366, 163553364, 163553362,
163553359, 163553354, 163553353, 163553346, 163553344,
163553342, 163553339, 163553337, 163553336, 163553333,
163553332, 163553331, 163553191, 163553190, 163553189,
163553188, 163553187, 163553186, 163553185, 163553183,
163553182, 163553181, 163553180, 163553179, 163553178,
163553177, 163553176, 163553175, 163553098, 163553094,
163553087, 163553086, 163553085, 163553084, 163553080,
163553038, 163553033, 163553028, 163553022, 163553021,
163553020, 163553016, 163553015, 163553011, 163553010,
163553009, 163553008, 163553007, 163553006, 163553005,
163553004, 163553003, 163553001, 163552974, 163552973,
163552972, 163552969, 163552965, 163552960, 163552959,
163552958, 163552955, 163552953, 163552950, 163552947,
163552946, 163552642, 163552941, 163552728, 163552727,
163552725, 163552724, 163552717, 163552335, 163552319,
163581775, 163581774, 163581771, 163581765, 163581734,
163581733, 163581731, 163581728, 163581727, 163581726,
163581725, 163581724, 163581723, 163581722, 163581720,
163581719, 163581716, 163581716, 163576140, 163576145,
163576147, 163576151, 163576152, 163577861, 163577867,
163577870, 163577885, 163578019, 163578026, 163578027,
163578028, 163578030, 163578031, 163578055, 163578080,
163581715, 163575789, 163571272, 163571208, 163571202,
163571189, 163571185, 163571075, 163571070, 163570981,
163570967, 163570798, 163570793, 163570790, 163570706,
163570735, 163570739, 163570198, 163570152, 163570041,
163570039, 163570038, 163570037, 163570036, 163570035,
163570034, 163570029, 163569963, 163569960, 163569959,
163569958, 163569957, 163569955, 163569952, 163569951,
163569950, 163569948, 163569947, 163569946, 163569945,
163569935, 163569933, 163569589, 163569588, 163569587,
163569586, 163569585, 163569583, 163569582, 163569580,
163569577, 163569560, 163569485, 163569479, 163569478,
163569476, 163569470, 163569468, 163569467, 163554871,
163554870, 163554868, 163554867, 163554866, 163554863,
163554862, 163554860, 163554858, 163554857, 163554853,
163554850, 163554847, 163554846, 163554843, 163554826,
163554825, 163554824, 163554823, 163554819, 163554818,
163554816, 163554815, 163554814, 163554808, 163554807,
163554806, 163554805, 163554803, 163554802, 163554801,
163554388, 163554387, 163554386, 163554385, 163554384,
163554383, 163554380, 163554379, 163554378, 163554374,
163554369, 163554367, 163554355, 163554354, 163554200,
163554199, 163554198, 163554197, 163554195, 163554194,
163554193, 163554192, 163554191, 163554190, 163554189,
163554188, 163554118, 163554102, 163554101, 163554197,
163554087, 163553809, 163553808, 163553807, 163553800,
163553411, 163553409, 163553407, 163553406, 163553194,
163553000, 163552999, 163552400, 163552398, and
163552329.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc.,Jackson, MS,by telephone and letter beginning February 17, 2001. Firm initiated recall complete.
REASON
Blood products, which were collected in a manner that compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 7 units;
b) 1 unit;
c) 689 units;
d) 2 units;
e) 140 units;
f) 46 units.
g) 534 units.
DISTRIBUTION
MS, AL, VA, MO and LA.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0123-3.
CODE
Unit number 15391-1460.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letter dated March 5, 2002. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Platelets, Apheresis, Recall # B-0128-3.
CODE
Units 4003142, 4003143.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter dated June 8, 2000. Firm initiated recall is complete.
REASON
Plateletpheresis products were distributed without platelet counts being performed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0132-3;
b) Recovered Plasma, Recall # B-0133-3.
CODE
a) Units 42T06044, 42T06045, 42T06046, 42T06047, 42T06049,
42T06050, 42T06051, 42T06052, 42T06053, 42T06054, 42T06055;
b) Units 42T06044, 42T06045, 42T06046, 42T06047, 42T06049,
42T06050, 42T06051, 42T06052, 42T06053, 42T06054,
42T06055.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letter dated January 16, 2002.
Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
OH.
PRODUCT
Red Blood Cells, Recall # B-0175-3.
CODE
Unit 27G78565.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by telephone on May 4, 2001.
Firm initiated recall is complete.
REASON
Blood product, not properly quarantined after receiving post donation information related to a probable sinus infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Source Plasma, Recall # B-0214-3.
CODE
Unit 71758503.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Champaign, IL, by fax on April 16, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the health history questions were not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Anti-Jka Blood Grouping Reagent, Recall # B-0220-3.
CODE
Lot number 1F4424; expiration date - July 11, 2003.
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter and/or fax on or about October 11, 2002. Firm initiated recall is complete.
REASON
Blood grouping reagent that during post release analysis demonstrated a reduction in potency, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4,412 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0221-3.
CODE
Unit number 15390-5165.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by letters on March 12, 2002 and April 30, 2002. Firm initiated recall is complete.
REASON
Blood product, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0227-3.
CODE
Unit number 26168-1556.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on July 30, 2001 and by letter dated August 23, 2001. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells Leukocytes Removed, Recall # B-0230-3.
CODE
Unit 261673676.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on August 14, 2001. Firm initiated recall is complete.
REASON
Blood product, which failed specifications for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
a) Red Blood Cells Leukocytes Removed, Recall # B-0231-3;
b) Recovered Plasma, Recall # B-0232-3.
CODE
a) and b) Unit 261674902.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by fax on July 10, 2001 and letter dated August 10, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who answered YES to having had surgery within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR and VA.
PRODUCT
Source Plasma, Recall # B-0234-3.
CODE
Unit number YP-41035.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by fax on August 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Recall # Z-0183-3/Z-0239-3.
The following products under the Centurion Healthcare Products brand:
Oral Swabs, Sodium Bicarb Treated, 2/Pkg., 800/case.
Latex-free. Reorder 3599SB2.
10/Pkg. Sodium Bicarb Oral Swabs, 100 per case. Reorder MC110SB.
20/Pkg. Sodium Bicarb Oral Swabs, Rorder MC120SB.
Admission Kits. Reorder H895.
Large Oral Swabs, 4000/case. Reorder 3599XT.
Plain Oral Swab, 1/package, 800/case, latex-free. Reorder 3599XT1.
Oral Swabs, 2/Package, 800/case. Latex-free. Reorder 3599XT2.
Mouth Care Kit, latex-free [contents 5 oral swabs], 100 per case. Reorder MC105.
Mouth Care Kit 5/pkg., latex-free [contents 5 plain oral swabs], 100 per case. Reorder MC105MG.
10/Pkg. plain Oral Swabs, 4 dispenser packs of 25 bags. Reorder MC110.
20/Pkg. Plain Oral Swabs; 50 pkgs per case. Reorder MC120.
Mouth Care Kit, latex-free [contents lip balm, mouth rinse, oral swabs]. Reorder: MC200.
Mouth Care Kit, latex-free [contents lip moisturizer, mouth rinse, plain oral swabs]. Reorder MC320.
Mouth Care Kit, latex-free [contents mouth rinse, medicine cup, mouth moisturizer, sodium bicarb oral swabs]. Reorder MC325.
The Medical Center Mouthcare Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC335.
Mouth Care Kit, latex-free [contents medicine cup, toothpaste, mouthwash, mouth moisturizer, oral swabs]. Reorder: MC340.
Large Mouth Care Kit, latex-free [contents oral swabs, mouth rinse, mouth moisturizer]. Reorder MC350.
Small Mouth Care Kit, latex-free [contents mouth rinse, oral swabs]. Reorder: MC355.
Mouth Care Kit, latex-free [contents mouth rinse - mint flavored, mouth moisturizer, mouthwash and oral swabs]. Reorder: MC370.
Mouth Care Kit, latex-free [contents mouth moisturizer, toothpaste, mouth rinse, plain oral swabs]. Reorder: MC390.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs. Reorder MC405.
Mouth Care Kit, latex-free [contents toothpaste, toothbrush, mouth moisturizer, mouthwash, oral swabs]. Reorder: MC410.
Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, medicine cup, oral swabs]. Reorder: MC420.
Mouth Care Kits, latex-free [contents mouth moisturizer,
toothpaste, mouthwash, oral swabs]. Reorder MC440.
Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, toothpaste, oral swabs]. Reorder: MC445.
Mouth Care Kit [contents 5 oral swabs], 50 per case. Reorder MC465.
Short Term Mouth Care Kit, latex-free [mouthwash and plain oral swabs]. Reorder: MC505.
Mouth Care Kit, latex-free [contents lip moisturizer, mouthwash, oral swabs]. Reorder MC520.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC540.
Oral Care Kit, latex-free [contents mouth moisturizer, mouthwash, oral swabs]. Reorder: MC550.
Mouth Care Kit with Suction-Swabstick, latex-free [contents mouth moisturizer, oral swabs, mouth care kits]. Reorder: MC585.
Mouth Care Protocol Kit, latex-free [contents large oral swabs, mouth moisturizer, mouth care kit]. Reorder: MC590.
Mouth Care Kit, latex-free [contents toothbrush, toothpaste, mouth moisturizer, peroxide, oral swabs]. Reorder: MC600.
Mini Mouth Care Kits, latex-free [contents peroxide and sodium bicarb swabs], 50 per case. Reorder MC605.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinses, toothpaste, oral swabs]. Reorder: MC620.
Mouth Care Kit, latex-free [contents mouth rinse, mouth
moisturizer, plain oral swabs]. Reorder: MC625.
Mouth Care Kit, latex-free [contents mouth rinse, mouth
moisturizer, medicine cup, plain oral swabs]. Reorder: MC655.
Mouth Care Kit, latex-free [contents mouth moisturizer, medicine cups, mouthwash, sodium bicarb swabs]. Reorder: MC660.
Mouth Care Kit with Plain Swabs, latex-free [contents mouth
moisturizer, mouth rinse, toothpaste plain oral swabs]. Reorder: MC665.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, sodium bicarb oral swabs]. Reorder: MC670.
Mouth Care Kit with SofTouch Suctioning Swab [contents toothpaste, mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC675.
Mouth Care Kit, latex-free [contents large oral swabs, mouth rinse, toothpaste]. Reorder: MC690.
Mouth Care Kit, latex-free. [contents 8 plain oral swabs]. Reorder MC730.
Mouth Care Kit, latex-free [contents mouth rinse and plain oral swabs]. Reorder: MC745.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, plain oral swabs]. Reorder: MC755.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC785.
Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, lip moisturizer, mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC795.
Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction devices, plain oral swab]. Reorder: MC800.
Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC820.
Mouth Care Kit, latex-free [contents medicine cup, lip moisturizer, mouth rinse, plain oral swabs]. Reorder: O80.
The following products under the Shield Healthcare Centers brand:
Code No. ENTKIT 1 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, oral care kits, tape, wipes, cath plugs].
Code No. ENTKIT 2 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, tape, cream, wipes, cath plugs, periwash, oral care kits].
Code No. ENTKIT 3 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, tape, cream, wipes, cath plugs, periwash, oral care kits].
Code No. ENTKIT 6 Enteral Feeding Kit (Gravity) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips].
Code No. ENTKIT 7 Enteral Feeding Kit (Gravity) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips].
Code No. ENTKIT 9 Enteral Feeding Kit (Pump) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips, cath plugs].
Code No. ENTKIT 12 Enteral Feeding Kit (Pump) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips, cath plugs].
CODE
Reorder 3599SB2. Lots 905062 and 906172.
Reorder MC110SB. Lots 908122 and 908262.
Rorder MC120SB. Lots 904292 and 907222.
Reorder: H895. Lots 505132, 506032, 506172 and 507012.
Reorder: 3599SB2. Lots 905062 and 906172.
Reorder: 3599XT. All swabs distributed after April 1, 2002. [do not bear lot numbers].
Reorder: 3599XT1. Lots 904082, 905062 and 905272.
Reorder: 3599XT2. Lot 906032.
Reorder: MC105. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC105MG. All kits distributed after April 1, 2002[do not bear lot numbers].
Reorder: MC110. Lot 905272.
Reorder: MC110SB. Lots 908122 and 908262.
Reorder: MC120. Lots 904222, 906242 and 907292.
Reorder: MC120SB. Lots 904292 and 907222.
Reorder: MC200. Lots 05062, 05202, 06242, 07292, 09162 and 08192.
Reorder: MC320. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC325. Lots 04082, 904082, 904222 and 906032.
Reorder: MC325. Lots 04082, 904082, 904222 and 906032.
Reorder: MC335. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC340. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC350. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC355. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC370. Lots 505202, 508262 and 507152.
Reorder: MC390. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC405. Lots 507152 and 508122.
Reorder: MC410. Lots 505202 and 508122.
Reorder: MC420. Lots 504082, 507082 and 509232.
Reorder: MC440. Lots 04222, 04292, 06172 and 08192.
Reorder: MC445. Lots 505132, 508032 and 508262.
Reorder: MC465. Lots 906172 and 904152.
Reorder: MC505. Lots 505202, 507292 and 509032.
Reorder: MC520. Lots 504152, 504292 and 504082.
Reorder: MC540. Lots 904012, 904222, 905272. 907292 and 908192.
Reorder: MC550. Lots 504012, 504292 and 507012.
Reorder: MC585. Lots 507152, 507292 and 509092.
Reorder: MC590. Lots 504292, 507082 and 507152.
Reorder: MC600. Lots 508122, 509032, 509092 and 509162.
Reorder: MC605. Lots 07222, 08122, 508052, 509232, 503252 and 505272.
Reorder: MC620. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC625. Lots 505272 and 509232.
Reorder: MC655. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC660. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC665. Lot 08122.
Reorder: MC670. Lots 504152, 505272 and 507152.
Reorder: MC675. Lot 509162.
Reorder: MC690. Lot 504152.
Reorder: MC730. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC745. Lot 507292.
Reorder: MC755. All kits distributed after April 1, 2002 [do not bear numbers].
Reorder: MC785. All kits distributed after April 1, 2002 [do not bear numbers].
Reorder: MC795. Lots 506172, 508192 and 508262.
Reorder: MC800. Lots 507012, 507292. 508052, 508192 and 508262.
Reorder: MC820. All kits distributed after April 1, 2002 [do not bear numbers].
Reorder: O80. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 1. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 2. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 3. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 6. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 7. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 9. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 12. All kits distributed after April 1, 2002 [do not bear numbers].
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-State Hospital Supply Corp., Howell, MI, by letters on October 11, 2002. Firm initiated recall is ongoing.
REASON
The sponge may become dislodged from the oral swab and present a choking hazard.
VOLUME OF PRODUCT IN COMMERCE
92,330 kits.
DISTRIBUTION
Nationwide.
PRODUCT
Bard LUMINEXX 7F Biliary Stent and Delivery System (length 60 cm). Recall # Z-0270-3;
Bard LUMINEXX 7F Vascular Stent and Delivery System (length 60 and 120 cm). Recall # Z-0271-3;
Bard LUMINEXX 7F Biliary Stent and Delivery System (length 80 and 120 cm). Recall # Z-0272-3;
memotherm-FLEXX Biliary Stent and Delivery System (length 60 cm). Recall # Z-0273-3;
memotherm-FLEXX Biliary Stent and Delivery System (length 80 and 120 cm). Recall # Z-0274-3;
memotherm-FLEXX Vascular Stent and Delivery System (length 60 and 120 cm). Recall # Z-0275-3.
CODE
All lots produced.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Peripheral, Vascular Tempe, AZ, by letter dated October 18, 2002.
Manufacturer: Division IMPRA Medica Munich, Germany.
Firm initiated recall is complete.
REASON
Sterile barrier compromised.
VOLUME OF PRODUCT IN COMMERCE
36,386.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
UroMax Ultra High Pressure Balloon Dilatation Catheters with HydroPlus Coating (kits) as follows:
a) UroMax Ultra Balloon Dilatation Catheters U2q/4-4/6/75,
10CC LWIG Kit, Catalog Number: 622512. Recall # Z-0276-3;
b) UroMax Ultra Balloon Dilatation Catheters U2q/8-8/6/75,
10CC LWIG Kit,Catalog Number: 622513. Recall # Z-0277-2.
CODE
a) Lot Number: 821010;
b) Lot Number: 823775.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp./Microvasive Urology, Div. Natick, MA, by letter on October 30, 2002.
Manufacturer: Boston Scientific Corp., Glens Falls, NY. Firm initiated recall ongoing.
REASON
Mislabeled: The unit carton for the UroMax Ultra 8mm-8cm kit contained a 4mm-4cm Balloon Catheter, and the UroMax Ultra 4mm-4cm kit contained a 8mm-8cm Balloon Catheter.
VOLUME OF PRODUCT IN COMMERCE
36 kits.
DISTRIBUTION
Nationwide.
PRODUCT
a) Endeavor 16-channel Neuromonitoring System;
b) VikingSelect 2, 4 or 8-channel Neuromonitoring System. Recall # Z-0279-3.
CODE
All lots produced.
RECALLING FIRM/MANUFACTURER
Nicolet Biomedical, Madison, WI, by letter on September 23, 2002. Firm initiated recall is outgoing.
REASON
Amplifiers used in the Endeavor and 8-channel VikingSelect Neuromonitoring Systems have a slow recovery from electrocautery so that physiologic signal monitoring can be delayed by up to several minutes.
VOLUME OF PRODUCT IN COMMERCE
a) 264;
b) 371.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
a) ExpressView Glucose 50 Test Strips, part Number 20025
is packaged 50 strips per vial and the vial is shrink wrapped. There is no outer carton/package. Recall # Z-0280-3;
b) In Charge Glucose Value pack, Part Number 30008 contains
two vials of 25 glucose test strips (for a total of 50
glucose test strips) and one vial of 4 GlucoProtien test
strips in one outer package/carton. (note: the
GlucoProtein Test Strips contained in the In Charge
Value Pack were previously recalled under recall numbers
Z-103-3 and Z-104-3.)Recall # Z-0281-3;
c) In Charge Glucose 50 Test Strips, Part Number 20005
contains two vials of 25 glucose test strips (for a
total of 50 glucose test strips) in one outer
package/carton. Recall # Z-0282-3.
CODE
a) Lot numbers 200250700833, 200250700825, 200250700798;
b) and c) Lot number 80120700790.
RECALLING FIRM/MANUFACTURER
LXN Corporation, San Diego, CA, by letters beginning October 21, 2002. Firm initiated recall is ongoing.
REASON
Stability failure.
VOLUME OF PRODUCT IN COMMERCE
17298.
DISTRIBUTION
Nationwide.
PRODUCT
Brand Name: ACS:180(R) Automated Chemiluminescence System Valproic Acid.
Common Name: ACS:180(R) Valproic Acid:
a) Catalog/Part Number 129216, 50 tests total:
Contents: 1 vial of ACS:180 Valproic Acid Lite Reagent,
1 vial of ACS:180 Valproic Acid Solid Phase, ACS:180
Valproic Acid Master Curve Card. Recall # Z-0283-3;
b) Catalog/Part Number 129217, 300 tests total:
Contents: 6 vials of ACS:180(R) Valproic Acid Lite
Reagent, 6 vials of ACS:180 Valproic Acid Solid Phase,
ACS:180 Valproic Acid Master Curve Card.
Recall # Z-0284-3.
CODE
a) Kit Lot Numbers 1987402, 2123203,2244103, 2308303,
2402804;
b) Catalog/Part # 129217: Kit Lot Numbers 1987502, 2123303,
284703, 2411704.
RECALLING FIRM/MANUFACTURER
Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by e-mail on October 4, 2002.
Manufacturer: Bayer Diagnostics, East Walpole, MA.
Firm initiated recall is ongoing.
REASON
Photo-oxidation of the ACS:180 Valproic Acid reagent has occurred due to inadequate instructions for storage.
VOLUME OF PRODUCT IN COMMERCE
a) 202 units;
b) 59 units.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Geo-Inserter for spinal implants, Catalog No. 1000-9015. Recall # Z-0285-3.
CODE
Lot 30963.
RECALLING FIRM/MANUFACTURER
Interpore Cross Intl., Irvine, CA, by letter on September 19, 2002. Firm initiated recall is complete.
REASON
Tips break while surgeon is seating implant.
VOLUME OF PRODUCT IN COMMERCE
11.
DISTRIBUTION
LA, GA, OH, NJ, WI and MO.
PRODUCT
T2 Screwdriver 3.5, extra short. Recall # Z-0286-3;
T2 Screwdriver Bit, short. Recall # Z-0287-3;
T2 Screwdriver bit, long. Recall # Z-0288-3;
T2 Screwdriver, long. Recall # Z-0289-3;
T2 Screwdriver, short. Recall # Z-0290-3;
T2 Compression Screwdriver Bit. Recall # Z-0291-3;
T2 Screwdriver Shaft. Recall # Z-0292-3;
Orthopedic Manual Surgical Instrument.
CODE
All tips under each Catalog Number.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letter on August 16, 2002.
Manufacturer: Stryker Trauma GmbH Kiel, Germany.
Firm initiated recall is ongoing.
REASON
The screwdrivers might be susceptible to intra-operative breakage at tip.
VOLUME OF PRODUCT IN COMMERCE
1238.
DISTRIBUTION
Nationwide.
PRODUCT
Quest Myocardial Protection System Back-up Set (MPSBUS), packaged within two molded-foam halves with the handle in a shipping box.
Instructions are place directly on the unit. Two disposable individually wrapped, sterile, pressure-monitor parts are included in a secondary box. Recall # Z-0300-3.
CODE
Catalog number 5001015
Serial Numbers 1032 through 1037.
RECALLING FIRM/MANUFACTURER
Quest Medical, Inc., Allen, TX, by letter on September 19, 2002. Firm initiated recall is ongoing.
REASON
Wrong size Roll pin (part), could cause the belt tensioner to disengage and result in stop of fluid flow during surgery.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
PA, IL and Kuwait.
PRODUCT
Little Soothers.
Classification Name: Cold Pack, The Little Soother is a 3 inch by 2 inch sealed plastic patch containing several ingredients including propylene glycol. The propylene glycol in the Little Soother acts to keep the device cool when the device is chilled. It was manufactured in three shapes: a yellow fish, a pink butterfly, and a blue penguin. There are 3 patches per unit container labeled in part, "xxx LITTLE SOOTHERS SET OF THREE xxx AVON wellness xxx". Recall # Z-0301-3.
CODE
Patches are not coded. Avon identifies the product under Style # FSC: F68115-1 which is also found on the back of the unit container. Little Soothers are featured in campaigns 16-18 (wellness What's New Extra).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Avon Products, Inc., New York, NY, by voice message on May 30, 2002.
Manufacturer: Won Yong, South Korea. Firm initiated recall is ongoing.
REASON
The product contains ethylene glycol instead of propylene glycol.
VOLUME OF PRODUCT IN COMMERCE
1129 units containing three (3) Little Soother patches each.
DISTRIBUTION
Nationwide.
PRODUCT
Hill-Rom brand Affinity Three birthing bed. Recall # Z-0302-3.
CODE
All beds with calf supports distributed between August 8, 2001 and September 18, 2002.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated October 17, 2002. Firm initiated recall is ongoing.
REASON
Calf support may become unstable.
VOLUME OF PRODUCT IN COMMERCE
200.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
AMPLATZER Delivery Systems. Recall # Z-0303-3.
7 French, Order Number 9-DEL-7F-45/80;
8 French, Order Number 9-DEL-8F-45/80;
9 French, Order Number 9-DEL-9F-45/80;
9 French, Order Number 9-DEL-9F-45/100;
10 French, Order Number 9-DEL-10F-45/80;
10 French, Order Number 9-DEL-10F-45/100;
12 French, Order Number 9-DEL-12F-45/80;
12 French, Order Number 9-DEL-12F-45/100.
b) AMPLATZER Exchange Systems:
12 French, Order Number 9-EXCH-12F-45/80.
CODE
AMPLATZER Delivery Systems.
RECALLING FIRM/MANUFACTURER
AGA Medical Corporation, Golden Valley, MN, by letters dated November 1, 2002. Firm initiated recall is ongoing.
REASON
Smaller than specified delivery cable screw diameter can lead to separation of device from delivery cable.
VOLUME OF PRODUCT IN COMMERCE
14910 AMPLATZER Delivery or Exchange Systems.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Accura Hemo Filtration Device, catalog #5M5660. Recall # Z-0304-3.
CODE
Catalog #5M5660 and Accura 01, serial numbers 0140, 0141,
0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0190, 0191,
0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0272, 0273,
0283, 0284, 0285, 0330, 0331, 0332, 0333, 0340, 0341, 0358,
0359, 0360, 0361, 0421, 0422, 0423, 0424, 0425, 0426, 0450,
0451, 0452, 0453, 0454, 0455, 0456, 0457, 0458, 0459, 0460,
0461.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Deerfield, IL, by e-mail on October 24, 2002.
Manufacturer: MeSys GmbH (Medizinische Systeme) Hanover.
Firm initiated recall is ongoing.
REASON
Blood leaks from the blood pump segment of the tubing set.
VOLUME OF PRODUCT IN COMMERCE
53 units.
DISTRIBUTION
Internationally.
PRODUCT
Monopolar needle electrode: disposable, sterile monopolar needle electrode used in electromyography (EMG) studies. Electromography is the measurement of skeletal muscle nerve activity. Recall # Z-0293-3/Z-0297-3.
Product is packaged and labeled in part "CADWELL Monopolar EMG Needle Electrodes Disposable/Pre-Sterilized ** 10 needles/package.
CODE
Cadwell P/N: 202207-000, 202208-000, 202704-000, 202209-
000, 202210-000;
Lot numbers: 1201XXX, 0202XXX, 0402XXX, 0602XXX, 0802XXX,
0102XXX, 0302XXX, 0502XXX, 0702XXX, 0902XXX.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cadwell Laboratories, Inc., Kennewick, WA, by letter dated September 27, 2002.
Manufacturer: Jari Electrodes, Gilroy, CA. FDA initiated recall is ongoing.
REASON
Inconsistent electrical performance of monopolar emg needles.
VOLUME OF PRODUCT IN COMMERCE
13,387.
DISTRIBUTION
Nationwide and Internationally.
END OF ENFORCEMENT REPORT FOR NOVEMBER 27, 2002
####
Enforcement Report Index | FDA News Page | FDA Home Page
Office of Public Affairs
Web page uploaded by clb 2002-NOV-27.