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U.S. Department of Health and Human Services

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Enforcement Report for April 13, 2005

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

April 13, 2005
05-15

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________

PRODUCT
a) Isabelle's Kitchen Seafood Italiano Supreme. The product is sold in 5 lb white plastic tubs, packed individually in white cardboard boxes. Recall # F-241-5;
b) Isabelle’s Kitchen Ceviche. The product is sold in 5 lb white plastic tubs, packed individually in white cardboard boxes. Recall # F-242-5.
CODE 
a) Date codes: Jan 7 05 355, Jan 9 05 357, Jan 14 05 362, Jan 16 05 364, and Jan 21 05 003;
b) Date code: Jan 11 05 356.
RECALLING FIRM/MANUFACTURER
Isabelle’s Kitchen, Inc., Harleysville, PA, by letter on January 11, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared crawfish (crustacea) and butter (milk).
VOLUME OF PRODUCT IN COMMERCE
211 tubs.
DISTRIBUTION 
PA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

 ______________________________

 PRODUCT
Smoked Salmon BBQ Style in vacuum packed package with stick on label stating SMOKED SALMON BBQ STYLE GRAND CHAMPION. Packages are of various net weights, each weighing approximately 1 lb. Recall # F-253-5.
CODE
PACKED ON FEB. 20, 05 SELL BY APR. 20, 05.
RECALLING FIRM 
Briney Sea Delicaseas, Tumwater, WA, by telephone on February 25, 2005 and by visit on February 26, 2005. Firm initiated recall is complete.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
110 lbs.
DISTRIBUTION 
WA.

_______________________________

 PRODUCT
Mrs. Redd’s Pineapple Pie, individually plastic wrapped, Net. Wt. 4.5 oz. Recall # F-254-5.
CODE
USE BY date of the product as : FEB 14, FEB 15, FEB 16, FEB 17, FEB 19, FEB 20, FEB 21, FEB 22 and FEB 23.
RECALLING FIRM/MANUFACTURER 
Mrs. Redd’s Pie Co., Inc., Colton, CA, by letter on February 14, 2005. Firm initiated recall is complete. 
REASON

Product contains undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
10,115 pies.
DISTRIBUTION 
CA, and Mexico.

 _______________________________

PRODUCT
a) Torn & Glasser World Variety Yogurt Trail Mix, 25 lb cartons. Recall # F-255-5;
b) Torn & Glasser Fruit & Nut Trail Mix, 5 lb and 25 lb carton. Recall # F-256-5;
c) Torn & Glasser Tropical Banana Trail Mix, 25 lb carton. Recall # F-257-5;
d) Torn & Glasser Everything Trail Mix, 25 lb carton. Recall # F-258-5;
e) Torn & Glasser Island Tropical Trail Mix, 25 lb carton. Recall # F-259-5;
f) Henry’s Marketplace and Sprouts Farmers Market Sweetened Diced Papaya packed in 11 lb plastic trays and 22 lb plastic tubs. Recall # F-260-5.
CODE
a), c), d), and e) The lot codes being recalled can be identified with the Julian date code stamped on the bottom of each case. The beginning date code 0013 ( January 1, 2004 ) up through and including 3654 (December 31, 2004 ).
b) The beginning date code 0014 ( January 1, 2004 ) up through and including 0395 ( February 8, 2005 ); f) All lot codes. The trays and tubs list a Best by date January 1, 2004 with the latest Best by date reflecting April 9, 2005.
RECALLING FIRM/MANUFACTURER 
Torn & Glasser Inc, Rancho Dominguez, CA, by telephone beginning February 10, 2005. Firm initiated recall is complete.
REASON
a) Product contains undeclared colors, FD&C Yellow #5 and #6;
b), c), d), e), and f) Product contains undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
5,468 cases.
DISTRIBUTION 
Nationwide.

_______________________________
PRODUCT
a) Product is Jose Madrid brand pineapple salsa packaged in 12 ounce jars. Recall # F-261-5;
b) Jose Madrid brand peach salsa. Recall # F-262-5.
CODE
030805 through 030807.
RECALLING FIRM/MANUFACTURER 
Jose Madrid Inc., Columbus, OH, by telephone beginning on March 9, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors, FD&C Yellow #5 and #6.
VOLUME OF PRODUCT IN COMMERCE
Total quantity distributed is 14,300/12 unit cases. This includes F-263-5, F-264-5, F-265-5, and the above recall numbers.
DISTRIBUTION 
OH, MI, IL, PA, NJ, MD, IN and internet sales.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

 

 _______________________________ 
PRODUCT
a) Ferrous Sulfate (iron) 27 mg tablets in plastic bottles packed under 5 different labels:
Pharmacist’s Choice brand IRON 96 TABLETS; select brand FERROUS SULFATE 100 TABLETS; FERROUS SULFATE 100 TABLETS Superior brand; OPTIMUM brand FERROUS SULFATE 100 TABLETS; OPTIMUM brand FERROUS SULFATE 250 TABLETS. Recall # F-244-5;
b) Prenatal vitamins, 100 tablets in plastic bottles packed under 3 different labels:
BARTELL DRUGS brand Prenatal Formula Multivitamin and Mineral; select brand PRENATAL TABLETS Multiple Vitamins & Minerals Supplement for Pregnant or Lactating Women; OPTIMUM brand PRENATAL FORMULA Multivitamin & Mineral Dietary Supplement. Recall # F-245-5;
c) Vitamin B-6 100 mg, 100 tablets in plastic bottles packed under 3 different labels: OPTIMUM brand; SELECT brand; BARTELL DRUGS brand. Recall # F-246-5;
d) Vitamin B-12 Sublingual 500 mcg, 100 tablets in plastic bottles labeled under 3 brands: SELECT brand; OPTIMUM brand; BARTELL DRUGS brand. Recall # F-247-5;
e) Vitamin B-12 100 mcg in 100 tablet plastic bottle under select brand label. Recall # F-248-5;
f) Niacin 100 mg 100 tablets in plastic bottle, select brand. Recall # F-249-5;
g) Vitamin C-500 mg USP in plastic bottles packed under 3 brands: Superior brand 100 tablet & 500 tablet bottles; BARTELL DRUGS brand in 100 tablet and 500 tablet bottles; OPTIMUM brand 100 tablets. Recall # F-250-5;
h) Selenium 200 mcg 60 tablet plastic bottles packed under two brands: OPTIMUM brand; SELECT brand. Recall # F-251-5;
i) Folic Acid 800 mcg USP, 250 tablet plastic bottle, OPTIMUM brand. Recall # F-252-5.
CODE
a) Lot #s 329539, 329540, 330166, 330165, 330909; all with expiration 11/07;
b) Lot #s 329796, 330168, 330169, 330683, 330883; all with expiration 10/07;
c) Lot #s 329714, 329578, 329164, 330487, 330684; all with expiration 11/07;
d) Lot #s 329640, 329904, 329992, 330046; all with expiration 11/07;
e) Lot #s 329641, 330393; expiration 11/07. Lot #s 327920, 328935, 329508; expiration 9/07;
f) Lot #s 329541, 329826, 330687; all with expiration date 11/08;
g) Lot #s 329109, 329355, 329490, 329430, 330183; all with expiration 10/08;
h) Lot #s 329926, 330053, 330194, 331116; all with expiration date 11/07;
i) Lot # 330375, expiration date 11/07.
RECALLING FIRM/MANUFACTURER 
Magno Humphries, Inc., Tigard, OR, by telephone beginning on March 8, 2005 and by letter on March 9, 2005. Firm initiated recall is ongoing.
REASON
Products may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
26,110 bottles.
DISTRIBUTION 
Nationwide.

_______________________________
PRODUCT

a) Product is Jose Madrid brand strawberry salsa packaged in 12 ounce jars. Recall # F-263-5;
b) Jose Madrid brand raspberry salsa packaged in 12 ounce jars. Recall # F-264-5;
c) Jose Madrid brand raspberry BBQ Chipotle salsa packaged in 12 ounce jars. Recall F-265-5.
CODE
030805 through 030807.
RECALLING FIRM/MANUFACTURER 
Jose Madrid Inc., Columbus, OH, by telephone beginning on March 9, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
Total quantity distributed is 14,300/12 unit cases. This includes F-261-5, F-262-5, and the above recall numbers.
DISTRIBUTION 
OH, MI, IL, PA, NJ, MD, IN and internet sales.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

 ______________________________ 
PRODUCT
Male Power Plus, maximum strength male sexual stimulant oral tablets, OTC, sold as a Dietary Supplement. Recall # D-181-5.
CODE
All codes.
RECALLING FIRM 
Spectrum Distribution & Marketing, Inc., Beverly Hills, CA, by letters on November 29, 2004, and press release on December 1, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared Taladafil.
VOLUME OF PRODUCT IN COMMERCE
105,000 tablets.
DISTRIBUTION 
Nationwide.
_______________________________ 
PRODUCT
a) METHYLIN Chewable Tablets, (Methylphenidate HCl),
2.5 mg, Rx only, 100 count bottles, ****
NDC 68188-132-01. Recall # D-182-5;
b) METHYLIN Chewable Tablets, (Methylphenidate HCl),
5 mg, Rx only, 100 count bottles, ****
NDC 68188-135-01. Recall # D-183-5;
c) METHYLIN Chewable Tablets, (Methylphenidate HCl),
10 mg, Rx only, 100 count bottles, ****
NDC 68188-137-01. Recall # D-184-5.
CODE
a) AMT20401A, AMT20402A, AMT20403A, AMT20404A;
b) AMT50401A, AMT50402A, AMT50403A, AMT50404A;
c) AMT100401A, AMT100402A, AMT100403A, AMT100404A;
RECALLING FIRM 
Alliant Pharmaceuticals, Alpharetta, GA, by letters on January 18, 2005 and February 10, 2005.
Manufacturer: Mallinckrodt Inc., St. Louis, MO. Firm initiated recall is ongoing.
REASON
Superpotent.
VOLUME OF PRODUCT IN COMMERCE
10,340/100-tablet bottles.
DISTRIBUTION 
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

 _______________________________ 
PRODUCT
a) Promethazine Hydrochloride Suppositories, USP,
12.5mg. Recall # D-179-5;
b) Promethazine Hydrochloride Suppositories, USP,
25mg, NDC 53265-762-12. Recall # D-180-5.
CODE
a) Lot, Exp. Date: 312016A, 11/05; 403120A, 02/06;
403207A, 03/06; 403208A, 03/06; 406094A, 05/06;
b) Lot, Exp. Date: 304085A, 04/05; 403053A, 02/06;
403054A, 02/06; 404080A, 02/06.
RECALLING FIRM/MANUFACTURER 
Able Laboratories, Inc., S Plainfield, NJ, by letters on February 11, 2005, and February 14, 2005. Firm initiated recall is ongoing.
REASON
Stability Failure.
VOLUME OF PRODUCT IN COMMERCE
1,916,213 units of 12.5 mg; 185,540 units of 25 mg.
DISTRIBUTION 
Nationwide.

 ______________________________ 
PRODUCT
Oxygen compressed, USP, in steel and aluminum cylinders, size M6, ML6, C (also referred to as M9), D, and E. Recall # D-185-5.
CODE
Cylinder serial numbers: D00143, D115847, D179383, D263955, D281785, D293051, D355188, D40255, D40261, D40264, D40266, D40674, D40675, D413746, D414051, D414888, D415864, D416763, D419058, D420116, D420123, 130446, 218144, 324205, 376585, 619682, 662196, 744281, 907781, 1102402, 1102416, 1975A, 265441F, 26782E, 268683D, 640396D, 718890E, 901501D, 90741F, 933279D, A139650, A472676, A50412433, A6888, A86469, A86485, A86491, A86503, A86524, A86530, A86579, A86581, A86591, A86620, A98240, A99080, AS0298919, AS0298923, S0298937, AS0298947, AS0298958, AS0298959, AS0298966, S0298973, AS0298975, AS0301087, AS0301089, AS0302288, AS0318835, AS0318858, AS0318862, AS0318866, AS0318883, AS0318887, AS0318908, AS0318914, AS0319815, AS0321425, AS0321429, AS0321443, AS0322017, AS0322030, AS0322033, AS0322055, AS0322058, AS0322059, AS0322076, AS0322087, AS0322088, AS0322090, AS0322298, AS0323860, AS0323877, AS0323897, AS0323899, AS0323903, AS0326742, AS0326781, AS0327877, AS0364885, AS0383387, AS0383999, AS0388066, AS0388121, AS0390421, AS0392872, AS0392947, AS0392949, AS0392976, AS0393947, AS0393948, AS0393954, AS0394005, S0394197, AS0394209, AS0394885, AS0394895, AS0398014, AS0398254, AS0399089, AS0399114, AS0399115, AS0399135, AS0399199, AS0412040, AS0412045, AS0412060, AS0412090, AS0412112, AS0412433, AS0416076, AS0417524, AS0417554, AS0417574, AS0418090, AS0420424, AS0420458, AS0420470, AS0420474, AS0420476, AS0420481, AS0422330, AS0422471, AS0422492, AS0422495, AS0422501, AS0422508, AS0422524, AS0425336, AS0425385, AS0425395, AS0425402, AS0425409, AS0425426, AS0425457, AS0425478, AS0427331, AS0427349, AS0427351, AS0427354, AS0427363, AS0427368, AS0427383, AS0427384, AS0427388, AS0427392, AS0427398, AS0427402, AS0427404, AS0427420, AS0427454, AS0599121, AS0932347, AS095023, AS095025, AS095050, AS095070, AS298923, AS322087, B008312, B215219, B28089, B28154, B40489, BX133121, BX133296, BX133299, BX133887, BX133900, BX133908, BX134955, BX135096, BX135607, BX138895, BX13928, BX13946, BX13966, BX349248, BX349251, BX349252, BX349254, BX349260, BX349261, BX349262, BX349263, BX349265, BX349265, BX349279, BX349280, BX349282, BX349284, BX349289, BX349298, BX349300, BX349315, BX349318, BX349322, BX349333, BX349334, BX349335, BX349337, BX349339, BX349340, BX349366, BX349369, BX349939, BX350634, BX35985, BX36394, BX36679, BX36751, BX376638, BX385598, BX385601, BX385609, BX385610, BX385611, BX385614, BX385779, BX386306, BX386318, BX386320, BX386321, BX386330, BX386344, BX386349, BX386362, BX386389, BX386396, BX386404, BX424412, BX430119, BX430136, BX430148, BX430154, BX430163, BX562606, BX6752, BX7350, BX7354, BX74515, BX74530, BX74596, BX848752, C66325, C68417, CA84238, E110762, E112141, E112163, E117868, E122619, E122680, E122738, E128092, E139583, E139588, E180676, E195147, E195347, E196503, E196504, E196508, E196512, E196525, E199822, E199963, E200499, E200502, E200508, E200513, E200519, E200526, E200591, E200693, E200702, E200716, E200725, E200728, E200732, E200733, E200746, E200748, E200749, E201166, E205114, E205128, E205176, E205254, E205262, E205273, E205278, E205279, E205339, E205369, E205371, E205374, E205384, E205386, E205388, E205401, E205402, E205406, E205425, E205762, E214095, E215219, E220749, E223581, E22889, E229009, E230347, E233994, E235161, E244807, E244880, E244887, E245668, E258528, E266490, E270987, E271823, E271829, E271831, E271850, E271979, E272256, E280369, E284083, E288657, E290369, E29905, E30179, E30278, E304264, E324370, E327920, E335514, E336947, E338632, E341101, E34746, E363570, E367552, E371670, E377019, E377446, E377814, E377816, E377819, E377820, E377825, E377827, E377830, E377837, E377841, E377846, E377851, E377852, E377853, E377856, E377862, E377876, E377877, E377881, E377883, E377887, E377891, E377994, E378042, E378046, E378804, E38087, E383859, E384411, E384428, E384440, E384441, E384445, E384451, E384459, E384460, E384473, E384477, E384483, E384493, E384499, E384500, E384508, E384509, E384511, E384513, E384682, E384709, E384719, E385475, E385714, E385726, E385737, E385746, E385755, E390324, E40359, E433631, E439768, E440417, E440418, E440419, E440420, E440425, E440427, E440645, E441089, E441092, E441095, E441098, E441099, E441100, E441101, E441104, E441106, E441107, E441110, E441111, E441112, E441116, E441121, E441125, E441130, E441134, E441136, E441140, E441141, E441142, E441145, E441147, E441152, E441157, E441159, E441163, E441164, E441166, E441169, E441173, E441701, E441711, E441723, E462085, E505563, E505581, E505592, E505604, E505609, E505627, E505662, E505671, E505751, E505759, E505760, E505766, E506147, E511777, E54439, E55225, E552451, E566313, E566315, E567568, E567839, E575739, E575746, E575800, E575801, E575809, E575814, E575815, E575819, MM1102482, MM1102483, MM1102487, MM1102495, MM1102497, MM1102499, MM1102584, MM1102798, MM1102811, MM1102816, MM1102826, MM1102828, MM1102829, MM1102830, MM1102831, MM1102855, MM1102862, MM1102871, MM1102881, MM1102886, MM1102911, MM1102918, MM1102919, MM1102922, MM1102950, MM1102952, MM1102953, MM1102960, MM1102961, MM1102971, MM1102977, MM1102982, MM1102983, MM1102984, MM1102987, MM1102989, MM1103099, MM1103108, MM1103110, MM1103143, MM1103147, MM1103153, MM1103159, MM1103164, MM1103166, MM1103167, MM1103174, MM1103187, MM1103527, MM1103530, MM1103546, MM1103548, MM1168262, MM1168356, MM1168529, MM1177478, MM1177481, MM1178006, MM1180442, MM1180448, MM1180449, MM1180456, MM1180457, MM1180461, MM1180491, MM1180658, MM1180699, MM1180713, MM1180724, MM1180725, MM1180728, MM1180740, MM1180741, MM1180936, MM1180937, MM1180938, MM1180941, MM1180944, MM1180945, MM1180946, MM1180946, MM1180947, MM1180949, MM1180951, MM1180954, MM1180957, MM1180959, MM1180960, MM1180961, MM1180966, MM1180969, MM1180974, MM1180975, MM1180976, MM1180979, MM1180986, MM1180987, MM1180989, MM1180994, MM1180996, AP0071959, AP0071968, AP0071977, AP0071982, AP0071991, AP0072002, AP0074875, AP010142, AP010147, AP010151, AP010158, AP010158, AP010160, AP010164, AP010165, AP010166, AP010167, AP010172, AP010180, AP010196, AP010202, AP010206, AP010212, AP011272, AP011343, AP011350, AP011352, AP011361, AP011371, AP011373, AP011379, AP011389, AP011407, AP011409, AP011525, AP011526, AP011532, AP011543, AP011562, AP011799, AP019242, AP019293, AP019294, AP019295, AP019296, AP020904, AP020907, AP020919, AP020920, AP020925, AP021031, AP021049, AP021068, AP021070, AP021080, AP021081, AP023399, AP064152, AP152953, BV12083, BV12945, BV23595, BV29092, BV29094, BV29096, BV29098, BV29101, BV29102, BV29103, BV29105, BV29109, BV29135, BV29142, BV32040, BV32947, BV35960, BV35979, BV35983, BV35985, BV35992, BV36000, BV36001, BV36003, BV36004, BV36007, BV36011, BV36013, BV36016, BV36023, BV36024, BV36040, BV36042, BV36599, BV36601, BV36626, BV36627, BV36679, BV36688, BV36705, BV36707, BV66587, BV66592, BV66604, BV66627, BV66631, BV66632, BV66637, BV66641, BV66659, BV66670, BV66674, BV66677, BV66687, BV66708, BV66711, BV66713, BV67745, BV68057, BV69433, BV70843, BV71055, BV71149, BV71342, BV71454, BV71588, BV71895, BV72154, BV72155, BV72406, BV72442, BV72814, BV7333, BV7342, BV7352, BV7354, BV7367, BV73721, BV73847, BV73966, BV74139, BV74433, BV74513, BV74515, BV74516, BV74518, BV74521, BV74522, BV74530, BV74533, BV74534, F34656, F34666, F34680, F34690, F34722, F34723, F34733, F34737, F34742, F34749, F34751, F34890, F37213, F37218, F37856, F39206, F39585, F39775, F39793, F39813, F40118, F40359, F40383, F41076, F41403, F42764, F43178, F43216, F43292, F43314, F43333, F44121, F44475, F46316, F46403, F46467, F48055, F50590, F51200, F53318, F53321, F53322, F53325, F53327, F53331, F53333, F53334, F53339, F53340, F53359, LL0278699, LL0278716, LL0278726, LL0278727, LL0278730, LL0278731, LL0278732, LL0278734, LL0278735, LL0278736, LL0278737, LL0278739, LL0278741, LL0278743, LL0278744, LL0278745, LL0278746, LL0278747, LL0278748, LL0278749, LL0278751, LL0278752, LL0278753, LL0278756, LL0278758, LL0278759, LL0278761, LL0278764, LL0278766, LL0278767, LL0278768, LL0278769, LL0278770, LL0278771, LL0278775, LL0278777, LL0278781, LL0278782, LL0278784, LL0278785, LL0278786, LL0278787, LL0278790, LL0278795, LL0278806, LL0278808, LL0278809, LL0278810, LL0278811, LL0278822, LL0278823, LL0279653, LL0279789, LL0301965, LL0301966, LL0301978, LL0301982, LL0302003, LL0302077, LL0302975, LL0302975, LL0302976, LL0302977, LL0302978, LL0302979, LL0302980, LL0302984, LL0302985, LL0302986, LL0302988, LL0302991, LL0302992, LL0302993, LL0302994, LL0302995, LL0302997, LL0303002, LL0303003, LL0303004, LL0303005, LL0303006, LL0303009, LL030301, LL0303012, LL0303013, LL0303014, LL0303019, LL0303019, LL0303021, LL0303022, LL0303023, LL0303024, LL0303027, LL0303028, LL0303031, LL0303033, LL0303034, LL0303035, LL0303039, LL0303041, LL0303044, LL0303049, LL0303050, LL0303053, LL0303057, LL0303058, LL0303060, LL0303061, LL0303062, LL0303063, LL0303065, LL0303065, LL0303066, LL0303069, LL0303070, LL0303071, LL0304889, LL0305007, LL0305033, LL0362312, LL0370798, LL0370801, LL0370802, LL0370811, LL0370815, LL0370816, LL0370822, LL0370824, LL0372243, LL0372302, LL0372305, LL0372307, LL0372312, LL0372314, LL0372320, LL0372321, LL0372323, LL0372337, LL0372347, LL0372384, LL0372385, LL0375095, LL0375096, LL0375102, LL0375107, LL0375111, LL0375112, LL0375115, LL0375118, LL0375129, LL0375130, LL0375131, LL0375136, LL0375137, LL0375140, LL0375142, LL0375144, LL0375147, LL0375151, LL0375152, LL0375161, LL0375164, LL0375172, LL0375175, LL0375178, LL0375180, LL0375325, LL0375326, LL0375331, LL0375337, LL0375340, LL0375363, LL061856, LL061857, LL061858, LL061862, LL061865, LL061871, LL061873, LL061878, LL061882, LL061886, LL061888, LL061889, LL061890, LL061891, LL061894, LL061895, LL061897, LL061898, LL061900, LL061902, LL061907, LL061909, LL061910, LL061911, LL061913, LL061915, LL061917, LL061921.
RECALLING FIRM 
Keelers Medical Supply Inc, Yakima, WA, by telephone beginning on March 15, 2005 and by letter on March 29, 2005. Firm initiated recall is ongoing.
REASON
GMP deviations including, but not limited to, failure to test product for purity and identity.
VOLUME OF PRODUCT IN COMMERCE
998 cylinders
DISTRIBUTION 
WA.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS II

 _______________________________ 
PRODUCT
FETALSCREEN. Recall # B-0854-5.
CODE
Lots FS451, FS452, FS453.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, NJ, by telephone on January 7, 2005. Firm initiated recall is complete.
REASON
FETALSCREEN test kits, demonstrating weak or negative reactivity with the positive control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5,808 kits, 3 lots.
DISTRIBUTION 
Nationwide and Internationally.

 _______________________________ 
PRODUCT
Human Tissue for Transplantation. Recall # B-0858-5.
a) CryoGraft, Achilles Tendon;
b) Semitendinosus/Gracilis Tendons;
c) CryoVein, Saphenous Vein;
d) CryoGraft, Tibialis Tendon;
e) CryGraft, Arotoiliac Artery;
f) CryoVein, Femoral Vein;
g) CryoGraft, Medial Meniscus Bone-Left;
h) CryoGraft, Quadriceps Tendon-Hemi;
i) CryoGraft, Hemi Patellar Tendon;
j) CryoGraft, Pulmonary Artery;
k) CryoGraft, Medial Meniscus Bone-Right;
l) Femoral-Popliteal Artery;
m) CryoGraft, Pulmonary Trunk Patch;
n) CryoGraft, Lateral Meniscus Bone-Left;
o) CryoVein, Femoral Vein with valve;
p) CryoGraft, Patellar Tendon, Whole;
q) CryoGraft, Pulmonary Monocusp Hemi-Artery-SG.
CODE
a) Donor #40205, Serial #4237153, Donor #40205, Serial #4237161, Donor #42334, Serial #4273184, Donor #42743, Serial #4283114, Donor #43376, Serial #4287127, Donor #44078, Serial #4314675, Donor #44161, Serial #4304965, Donor #44874, Serial #6684820, Donor #47377, Serial #6817189, Donor #49840, Serial #6884820, Donor #50007, Serial #7097239, Donor #50491, Serial #7136220;
b) Donor #39486, Serial #4232127, Donor #40205, Serial #4243838, Donor #42334, Serial #4273249, Donor #43543, Serial #4300965, Donor #43921, Serial #4310590, Donor #44161, Serial #6661976, Donor #44343, Serial #4306160, Donor #45620, Serial #6710115, Donor #48046, Serial #6841255, Donor #49840, Serial #6889818, Donor #50007, Serial #7103288, Donor #50505, Serial #7142949, Donor #52822, Serial 7060782, Donor #54197, Serial #7216030, Donor #54197, Serial #7220332, Donor #54756, Serial #7218658, Donor #57383, Serial #7320357;
c) Donor #40205, Serial #6553788, Donor #41907, Serial #6599621, Donor #42357, Serial #6614914, Donor #42539, Serial #6615988, Donor #42822, Serial #6626599, Donor #42898, Serial #6634087, Donor #43276, Serial #6647996, Donor #43276, Serial #6648019, Donor #43543, Serial #4300645, Donor #43543, Serial #4300690, Donor #43921, Serial #4308516, Donor #44385, Serial #6668752, Donor #45564, Serial #6724601, Donor #45879, Serial #6725908, Donor #47396, Serial #6840601, Donor #47563, Serial #6769018, Donor #47563, Serial #6769053, Donor #47810, Serial #6812564, Donor #48551, Serial #6805622, Donor #48923, Serial #6859237, Donor #50731, Serial #7006363, Donor #52050, Serial #7037340, Donor #52101, Serial #7125063, Donor #53358, Serial #7266253, Donor #54213, Serial #7286677, Donor #55139, Serial #7238163, Donor #55551, Serial #7155385, Donor #56156, Serial #7294558, Donor #57045, Serial #7389855, Donor #57383, Serial #7458784;
d) Donor #40482, Serial #4245105, Donor #40658, Serial #4267702, Donor #42334, Serial #4273265,
Donor #43531, Serial #4298960, Donor #43531, Serial #4303686, Donor #43541, Serial #4299968,
Donor #43543, Serial #4300956, Donor #43921, Serial #4305381, Donor #44727, Serial #6683408,
Donor #44908, Serial #6677200, Donor #47377, Serial #6816973, Donor #47377, Serial #6817267,
Donor #47563, Serial #6797186, Donor #48038, Serial #6831542, Donor #48038, Serial #6831576,
Donor #48046, Serial #6839019, Donor #48923, Serial #6846991, Donor #49840, Serial #6891073,
Donor #50491, Serial #7143846, Donor #50505, Serial #7007618, Donor #50505, Serial #7142965,
Donor #51119, Serial #7042347, Donor #51818, Serial #7039379, Donor #52543, Serial #7063510,
Donor #52822, Serial #7126124, Donor #53545, Serial #7020110, Donor #54056, Serial #7210499,
Donor #54056, Serial #7210543, Donor #54068, Serial #7216624, Donor #54080, Serial #7204438,
Donor #54471, Serial #7283591, Donor #54474, Serial #7287478, Donor #54474, Serial #7287483,
Donor #54676, Serial #7182629, Donor #54756, Serial #7213614, Donor #54756, Serial #7213621,
Donor #54756, Serial #7218632, Donor #55299, Serial #7228353, Donor #57412, Serial #7451149,
Donor #57412, Serial #7453116, Donor #57538, Serial #7403808;
e) Donor #42048, Serial #6601936, Donor #57045, Serial #7303651;
f) Donor #42048, Serial #6602983, Donor #47396, Serial #6823052, Donor #47810, Serial #6813725,
Donor #47946, Serial #6842949, Donor #52318, Serial #7128210, Donor #55551, Serial #7158126,
Donor #57123, Serial #7317690, Donor #58134, Serial #7423827;
g) Donor #42285, Serial #4277287, Donor #42926, Serial #6643901, Donor #50505, Serial #7137749,
Donor #57045, Serial #7439333;
h) Donor #42285, Serial #4277333, Donor #42334, Serial #4273222, Donor #42926, Serial #6643867,
Donor #55551, Serial #7155689;
i) Donor #39803, Serial #4238249, Donor #42285, Serial #4277414, Donor #42334, Serial #4273214, Donor #42743, Serial #4281872, Donor #43531, Serial #4298999, Donor #44161, Serial #4309599, Donor #46162, Serial #6729798, Donor #47042, Serial #6779199, Donor #47377, Serial #6817221, Donor #48046, Serial #6838991, Donor #48673, Serial #6802485, Donor #48923, Serial #6848964, Donor #49063, Serial #6846765, Donor #48940, Serial #6885394, Donor #50505, Serial #7137729, Donor #50608, Serial #7142637, Donor #52213, Serial #7085784, Donor #54474, Serial #7286884, Donor #57436, Serial #7320787;
j) Donor #42409, Serial #6619959, Donor #52796, Serial #7072290, Donor #54197, Serial #7176168;
k) Donor #42539, Serial #4284122, Donor #47042, Serial #6779189, Donor #48797, Serial #6893056,
Donor #48923, Serial #6847825, Donor #50608, Serial #7142613, Donor #50703, Serial #7005438,
Donor #52822, Serial #7125857, Donor #54056, Serial #7184433, Donor #54197, Serial #7215958,
Donor #55621, Serial #7243611, Donor #57383, Serial #7397977, Donor #57656, Serial #7456757;
l) Donor #44635, Serial #6692839, Donor #45620, Serial #6734318, Donor #51818, Serial #7032820,
Donor #52097, Serial #7037706, Donor #52097, Serial #7037719, Donor #55393, Serial #7247045,
Donor #57045, Serial #7316929;
m) Donor #46111, Serial #6723904;
n) Donor #52213, Serial #7037494;
o) Donor #52818, Serial #7120893;
p) Donor #54080, Serial #7204457, Donor #57884, Serial #7432991;
q) Donor #57172, Serial #7310447.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letters dated May 6, May 11, or May 12, 2004. Firm initiated recall is on going.
REASON
Human tissue, associated with positive microbiological culture results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
165 tissues.
DISTRIBUTION 
Nationwide and Internationally.

 ______________________________ 
PRODUCT
a) Red Blood Cells. Recall # B-0865-5;
b) Red Blood Cells (Apheresis). Recall # B-0866-5;
c) Red Blood Cells, Leukocytes Reduced.
Recall # B-0867-5;
d) Red Blood Cells (Apheresis) Leukocytes Reduced.
Recall # B-0868-5;
e) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0869-5;
f) Red Blood Cells, Washed. Recall # B-0870-5;
g) Red Blood Cells, Leukocytes Reduced, Washed.
Recall # B-0871-5;
h) Red Blood Cells, Deglycerolized, Leukocytes
Reduced. Recall # B-0872-5;
i) Red Blood Cells, Frozen. Recall # B-0873-5;
j) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0874-5;
k) Platelets Pheresis, Leukocytes Reduced,
Irradiated. Recall # B-0875-5;
l) Platelets Pheresis Irradiated, Recall # B-0876-5;
m) Fresh Frozen Plasma. Recall # B-0877-5;
n) Fresh Frozen Plasma (Apheresis).
Recall # B-0878-5;
o) Plasma Frozen. Recall # B-0879-5;
p) Recovered Plasma. Recall # B-0880-5.
CODE
Blood products, collected between May 30, 2002 and March 8, 2004, of the above types:
RECALLING FIRM 
American Red Cross, New England Region, Dedham, MA, by telephone on March 16, 2004, and by letters, dated June 11, 2004. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16,393.
DISTRIBUTION 
Nationwide.
_______________________________ 
PRODUCT

a) Red Blood Cells. Recall # B-0881-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0882-5;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated. Recall # B-0883-5;
d) Platelets. Recall # B-0884-5;
e) Platelets, Irradiated. Recall # B-0885-5;
f) Fresh Frozen Plasma. Recall # B-0886-5;
g) Plasma. Recall # B-0887-5;
h) Red Blood Cells for Further Manufacture
of Non-injectables. Recall # B-0888-5.
CODE
Products collected between April 2001 and July 2003, of the above types:
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by facsimile, telephone, and letter beginning July 24, 2003, and a follow-up letter, on October 9, 2003. Firm initiated recall is on going.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,279 units.
DISTRIBUTION 
PA, WV, OH, MD, KY, VA, SC, MA, NC, and GA.

 _______________________________ 
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0889-5;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated. Recall # B-0890-5.
CODE
a) Units 4383991 (split unit), 4217025 (split unit),
0109018 (split unit);
b) Units 4217025, 0109018.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated May 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION 
TX.

 _______________________________ 
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0912-5;
b) Platelets, Leukocytes Removed.
Recall # B-0913-5.
CODE
a) and b) Unit number: 19LM18516.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter, dated January 7, 2003.
Manufacturing Firm: American Red Cross, Tennessee Valley Region, Murfreesboro, TN. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with coagulase-negative, Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION 
TN, and KY.

 _______________________________ 
PRODUCT
a) Platelets, Leukocytes Removed.
Recall # B-0914-5;
b) Fresh Frozen Plasma. Recall # B-0915-5.
CODE
a) and b) Unit number: 19LY67676.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter, dated August 29, 2002. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with coagulase-negative, Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN, and GA.
_______________________________ 
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0916-5;
b) Fresh Frozen Plasma. Recall # B-0917-5.
CODE
a) Unit numbers: 19GM25728, 19GM25730,
19GR52929, 19GR52935, and 19GR52937;
b) Unit numbers: 19GR52929, 19LM23591.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by letter, dated April 9, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TN, and KY.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0921-5.
CODE
Unit 93V11382.
RECALLING FIRM/MANUFACTURER
The Cooley Hospital Blood Bank, Northampton, MA, by letter dated January 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which was confidentially identified by the donor to be excluded for donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________ 
PRODUCT
Red Blood Cells Apheresis Leukocytes Reduced. Recall # B-0924-5.
CODE
Unit 02KF01726.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on October 25, 2004 and by letter dated November 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0925-5.
CODE
Unit 182357406.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone and by letter dated September 20, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Wyoming and Switzerland

 _______________________________ 
PRODUCT
Source Plasma. Recall # B-0927-5.
CODE
Units 98MWIB7456 and 98MWID2954.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Menasha, WI, by letter dated July 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0928-5.
CODE
Units 12K95373, 12R41197.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 17, 2004. 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
NC.
_______________________________ 
PRODUCT

a) Red Blood Cells. Recal # B-0929-5;
b) Platelets. Recall # B-0930-5;
c) Recovered Plasma. Recall # B-0931-5.
CODE
a), b), and c) Unit 19GW34523.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Nashville, TN, by facsimile and by letter dated July 16, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who provided a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
KY, and CA.

_______________________________
PRODUCT

Red Blood Cells, Leukocytes Reduced. Recall # B-0938-5.
CODE
Unit 12M25628.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 4, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of cancer, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________ 
PRODUCT

a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0942-5;
b) Fresh Frozen Plasma. Recall # B-0943-5.
CODE
a) and b) Unit number: 19LM23659.
RECALLING FIRM/MANUFACTURER
American Red Cross, Tennessee Valley Region, Nashville, TN, by telephone and by letter, dated April 15, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT

Red Blood Cells. Recall # B-0948-5.
CODE
Unit number: 12LR15625.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on September 8, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________ 
PRODUCT
Platelets. Recall # B-0950-5.
CODE
Unit KL11943.
RECALLING FIRM/MANUFACTURER
Lancaster Regional Medical Center, Lancaster, PA, by letter dated August 27, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT

Recovered Plasma. Recall # B-0926-5.
CODE
Unit 182357406.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone and by letter dated September 20, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Wyoming and Switzerland 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

 _______________________________ 
PRODUCT
MicroScan Ô Rapid Pos Inoculum Broth, Catalog #: B1015-14. Recall # Z-0668-05.
CODE
Lot Nos: 050905A-1, 051005A-1, 051605A-1, 051705A-1, 052305A-1, 052805B-1.
RECALLING FIRM/MANUFACTURER
Dade Behring Inc, West Sacramento, CA, by letters on January 27, 2005 and February 10, 2005. Firm initiated recall is ongoing.
REASON
There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
VOLUME OF PRODUCT IN COMMERCE
324 boxes.
DISTRIBUTION
Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

 _______________________________ 
PRODUCT
PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: • Siemens Models: Biograph PET/CT • CTI Models: Reveal PET/CT. Recall # Z-0547-05.
CODE
0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007, 096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015, 096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007, 096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014, 096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002, 214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016, 214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006, 214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013, 214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021, 214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028, 214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035, 214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042, 216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015, 216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022, 216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024.
RECALLING FIRM 
CTI PET Systems, Inc, Knoxville, TN, by letter on May 27, 2004. Firm initiated recall is ongoing.
REASON
Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.
VOLUME OF PRODUCT IN COMMERCE
214.
DISTRIBUTION
Nationwide and Internationally.

 _______________________________ 
PRODUCT
CryoValve, Pulmonary Valve and Conduit. Donor Number: 70022, Model Number: PV00. Recall # Z-0669-05.
CODE
Serial Number: 8056613.
RECALLING FIRM/MANUFACTURER
Cryolife Inc., Kennesaw, GA, by letter on January 12, 2005. Firm initiated recall is complete.
REASON
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
KS.

 _______________________________ 
PRODUCT
Electri-Cool II. Recall # Z-0670-05.
CODE
All units manufactured from 3/04-5/04.
RECALLING FIRM
Cincinnati Sub-Zero Products, Cincinnati, OH, by letter dated January 18, 2005. Firm initiated recall is ongoing.
REASON
There is the potential that the power switch assembly can dislodge from the cabinet during use.
VOLUME OF PRODUCT IN COMMERCE
116 devices.
DISTRIBUTION
Nationwide.
_______________________________ 
PRODUCT
Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05.
CODE
All units containing version 0.70 software.
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated January 18, 2005. Firm initiated recall is ongoing.
REASON
There is the potential that the power switch assembly can dislodge from the cabinet during use.
VOLUME OF PRODUCT IN COMMERCE
553 devices.
DISTRIBUTION
Nationwide.
_______________________________ 
PRODUCT
a) Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube
with modified tip for left bronchial intubation, 37 Fr.; sold under the following catalog numbers:

  • catalog number (REF) V5-16037: Novaplus Sterile

Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation,

  • catalog number (REF) 5-16037: Hudson RCI Sheridan

Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr. Recall # Z-0680-05;
b) Sheridan Sher-I-Bronch Endobronchial Tube for Right
Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; catalog number (REF) 5-16137. Recall # Z-0681-05.
CODE
a) a) Lot number 1145385; b) Lot numbers 1147855
and 1146242;
b) L ot numbers 1148460 and 1147062.
RECALLING FIRM 
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letter on February 23, 2005.
Manufacturer: Hudson RCI Tecate S. de R.L. de C.V., Mexico. Firm initiated recall is ongoing.
REASON
The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating "Bronchial - Right" instead of "Bronchial - Left", and catalog number 5-16137 stating "Bronchial - Left" instead of "Bronchial - Right".
VOLUME OF PRODUCT IN COMMERCE
4,941 units.
DISTRIBUTION
Nationwide and Internationally.

 _______________________________ 
PRODUCT
Tomoscan. Recall # Z-0682-05.
CODE
The firm utilizes site numbers: 6902, 6916, 6975, 6976, 13568, 13616, 13701, 13881, 13945, 14054, 15313, 17178, 17363, 17393, 17438, 17447, 26147, 35424, 35466, 35487, 35499, 37835, 37975, 38026, 38107, 38112, 38264, 38282, 38302, 38347, 38404, 38560, 38596, 38638, 38659, 38721, 38723, 38983, 40234, 40313, 40318, 40387, 41078, 41087, 41194, 41331, 41332, 41338, 41400, 41427, 41428, 41429, 44291, 44710, 44715, 44830, 45021, 45055, 45056, 46641, 50149, 50166, 50304, 50404, 59280, 59287, 59378, 59456, 59537, 59651, 59657, 59705, 62358, 62613, 62654, 62793, 62836, 62860, 62943, 62944, 68203, 73906, 73958, 73990, 74004, 74005, 74020, 76037, 76211, 76361, 76367, 76415, 76416, 76598, 76599, 76929, 82611, 82649, 82830, 82900, 83049, 83055, 84426, 85076, 86024, 86363, 104223, 104301, X0191, X0206, X0224, X0247, X0733, X0927, X1018, X1047, X1058, X1129, X1130, X1133, X1170, X1187, X1213, X1214, X1243, X1245, X1307, X1354, X1368, X1369, X1370, X1432, X1479, X1481, X1482, X1532, X1533, X1672.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems Sales and Service, Region No. America, Bothell, WA, by on site visit, beginning on February 10, 2005.
Manufacturer: Hitachi Medical Systems, CT Product Division, Kashiwa, Japan. Firm initiated recall is ongoing.
REASON
Potential for shift of reference lines.
VOLUME OF PRODUCT IN COMMERCE
138 devices.
DISTRIBUTION
Nationwide.

 _______________________________ 
PRODUCT

a) CryoValve, Aortic Valve & Conduit SG. Donor #63601,
Model #SGAV00. Recall # Z-0683-05;
b) CryoValve, Pulmonary Valve & Conduit. Donor #65989,
Model #PV00. Recall # Z-0684-05;
c) CryoValve, Aortic Valve & Conduit. Donor #75651,
Model #AV00.
Recall # Z-0685-05.
CODE
a) Serial #7846205;
b) Serial #8095375;
c) Serial #7439561.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letters dated December 17, 2004, January 3, 2005, and January 19, 2005. Firm initiated recall is ongoing.
REASON
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the “Last Seen Alive” time in their calculation.
VOLUME OF PRODUCT IN COMMERCE
3 tissues.
DISTRIBUTION
CA, NJ, and TX.

RECALLS AND FIELD CORRECTIONS: Devices - CLASS III

_______________________________
PRODUCT

a) Latex-Free REF B1000, Belly Bag Urine Collection
Bag with Hip Belt,***1000 ml Lot ***Sterile EO.
Recall # Z-0647-05;
b) Latex-Free REF B1000P Belly Bag Urine Collection
Bag with Sample Port ***1000 ml Lot ***Sterile
EO*** Single use only. Recall # Z-0648-05.
CODE
a) Lots 121870, 121871, 121872, 122515, 122517, 122518, 123273, 123274, 123275, 124066, 124333
and 124334;
b) Lots 121848, 122514, 124332, 125309 and 125885.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Inc., Duluth, GA, by letter on May 13, 2004 and November 22, 2004.
Manufacturer: Rusch Inc, Duluth, GA. Firm initiated recall is ongoing.
REASON
Firm received complaints of leaking urine collection bags.
VOLUME OF PRODUCT IN COMMERCE
7,256 bags.
DISTRIBUTION
Nationwide, Australia, Japan and the UK.

 _______________________________ 
PRODUCT

a) Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers;
catalog 20753521322. Recall # Z-0649-05;
b) Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
Recall # Z-0650-05;
c) Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.
Recall # Z-0651-05.
CODE
a) Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153,
650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104;
b) Lots 646340, 650984, 651640 and 653292;
c) Lots 645515, 650134, 655120, 660108.
FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, letters dated February 15, 2005. Firm initiated recall is ongoing.
REASON
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
VOLUME OF PRODUCT IN COMMERCE 
347,000 Integra cassettes and 1,800 MIRA kits.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR APRIL 13, 2005

 

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