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Enforcement Report for August 29, 2007

Enforcement Report

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

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August 29, 2007
07-35

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Parsley Powder, Dehydrated, bulk, a) World Spice Inc; b) Labeled for Dehydrates, Inc; c) Labeled for Van deVries/Atlantic Spice, Recall # F-477-7
CODE
a) Lot #960; b) Lot 4522, 4600 and 4601; c) Lot 21966
RECALLING FIRM/MANUFACTURER
World Spice, Inc., Roselle, NJ, by telephone and e-mail beginning on July 30.2007. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella. They are associated with an outbreak of Salmonella illness.
VOLUME OF PRODUCT IN COMMERCE
16,750 pounds
DISTRIBUTION
NJ and NY
___________________________________
PRODUCT
Veggie Booty recalled by Robert's American Gourmet contained in Well Baskets Gifts as follows: Gift Basket Item Code Healthy Birthday for Her sampler GB02B205 Healthy Birthday for Her GB02B204 Healthy Athlete Birthday Basket For her GB02B202 Healthy Congratulations Basket GB02C402 Sympathy Basket GB02C503 With Sympathy Basket GB02S503 Deluxe Sympathy Basket GB02S503 Thank You Healthy Sentiments GB02T202 Healthy Valentines Day Gift Basket GB03VA10 My Valentine Basket GB03VA16 Little Valentines GB03VA14 My Valentine Deluxe Basket GB03VA05 Our Deluxe Women’s Healthy Valentines Day Gift Basket GB03VA07 Women’s Healthy Valentines Day Gift basket GB03VA23 Shamrock Delight GB03SP01 Happy Spring GB03EA11 Easter Goodies GB03EA08 College Student Easter Basket GB03EA14 The Healthy Assistant Gift Basket GB03SE04 The Deluxe Healthy Mothers Day Gift Basket GB03MO03 The Healthy Mothers Day Basket GB03MO06 The Big Daddy GB03DA09 Healthy Halloween GB03HA01 Seasons greetings Gift Basket GB03CH12 Low Sugar Deluxe Gift Basket GB05S306 Low Sugar Gift Basket GB05S307 Vegan GB05S314 Vegetarian GB05S316 Seasonal Allergy relief Basket GB01A102 Deluxe Allergy Relief Basket GB01A101 Deluxe Anxiety Relief Basket GB01A203 Anxiety Relief Basket GB01A201 Athlete Health basket GB01A302 Athlete Health Sampler GB01A301 Deluxe Athletes Health Basket GB01A303 Cancer Patient Snacker GB01C105 Healthy Gift Basket for Children GB01C208 Children’s Get Well GB01C204 Healthy Camper GB01C207 BooBoo Basket GB01C202 Healthy College Student Care Package GB01C302 Healthy College Student Sampler Care Package GB01C303 Exam Survival GB01C301 LDS Missionary Package GB01C305 Depression Relief Healthy Sentiments GB01D102 Depression Relief Basket GB01D103 Deluxe Depression Relief Basket GB01D101 Super Deluxe Depression Relief Basket GB01D104 Gall Bladder Health GB01D302 Energizing Basket for Him GB01E102 Deluxe Get Well Basket GB01G101 Super Deluxe Get Well basket GB01G104 Golfer's Healthy Basket GB01G205 Deluxe Golfers Healthy Gift Basket GB01G201 Healthy Hiker GB01G401 Immunity Boosting GB01I101 immunity Boosting Snacker GB01I102 Insomnia Relief GB01I201 Marathon Runner Sampler Basket GB01M103 Marathon Runner Gift Basket GB01M102 Marathon Runner Deluxe Gift Basket GB01M101 Marathon Runner Super Deluxe Basket GB01M105 Men’s Health Sampler Basket GB01M302 The Menopause Health Basket GB01M402 Guided Imagery Deluxe Menopause Health Basket GB01M401 Guided Imagery Menopause Health Basket GB01M404 Deluxe Menopause Health Basket GB01M406 Over the hill Menopause Health Basket GB01M405 Pain Relief Sampler Basket GB01P104 Pain Relief Basket GB01P103 Deluxe pain Relief basket GB01P102 Super Deluxe Pain Relief Basket GB01P106 Our Better than Aspirin Pain Relief Basket GB01P101 Pain Relief Guided Imagery Gift Basket GB01P107 Healthy Pregnancy Sampler Gift Basket GB01P203 Healthy Pregnancy Gift Basket GB01P202 Deluxe Healthy Pregnancy Gift Basket GB01P201 Stop Smoking Sampler Basket GB01S103 The Stress Relief Basket GB01S202 The Deluxe Stress Relief Basket GB01S201 The Stress Relief Sampler Basket GB01S203 Hyperthyroidism basket GB01T101, Recall # F-479-7
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Well Baskets, LLC, Newtown, CT, by e-mail and telephone on June 29, 2007, and by press release on July 2, 2007.
Manufacturer: Robert’s American Gourmet Food, Inc., Sea Cliff, NY. Firm initiated recall is ongoing.
REASON
Veggie Booty (recalled by Robert 's American Gourmet due to Salmonella contamination) was included in gift baskets.
VOLUME OF PRODUCT IN COMMERCE
753 baskets
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Home Special Health Soup Recipe, Net Wt. 5.3oz. (150g+-5g). Product of China. Serving Size: 1/6 cup (24g), Servings Per Container: 4 --- Product is also labeled in Chinese language, Recall # F-482-7
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading Inc., Brooklyn, NY, by press release on January 2, 2007.
Manufacturer: Sinojet Development LTD, Hong Kong, China (Mainland). Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (478 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
42 cases (60 - 5.3 oz. packages per case)
DISTRIBUTION
NJ, NY, FL, GA, IL, KY, MA, MN, MO, NC, SC, OH, MD
___________________________________
PRODUCT
Lucky Eight Brand Dried Lily Bulb, Net. Wt. 12oz (340g). Product of The People's Republic of China --- UPC 7 67533 80097 1. The product is packaged in a sealed, flexible plastic bag, Recall # F-483-7
CODE
No code
RECALLING FIRM/MANUFACTURER
Murray International Trading Co., Inc., Brooklyn, NY, by press release and letter on May 29, 2007. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (651 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
882 – 12 oz. bags
DISTRIBUTION
NY
___________________________________
PRODUCT
a) Robert's American Gourmet brand Veggie Booty, With Spinach and Kale.
    The product is sold in 1/2 oz. (UPC 15665-60128-8), 1 oz. (UPC 15665-60122-6),
    and 4 oz. (UPC 15665-60915-4) flexible, plastic foil bags, Recall # F-484-7;
b) Robert's American Gourmet brand Super Veggie Tings Crunchy Corn Sticks,
    With Spinach and Broccoli, Net wt. 6 oz. (168g). The product is packaged in flexible,
    plastic foil bags, UPC 15665-10356, Recall # F-485-7
CODE
All codes and expiration dates   
RECALLING FIRM/MANUFACTURER
Recalling Firm: Robert's American Gourmet Food, Inc., Sea Cliff, NY, by press release on June 28, 2007 and July 2, 2007, and by telephone and letters on June 29, 2007 and July 2, 2007.
Manufacturer: Keystone Food Products Inc., Easton, PA. Firm initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella. The product is associated with a multi-state outbreak of Salmonella Wandsworth.
VOLUME OF PRODUCT IN COMMERCE
VB: 90,236 cases (12-4oz bags per case); 6406 cases (24-1oz bags per case); 232 cases (60-½ oz bags per case); SVT: 3813 cases (12-6oz bags per case)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) MaraNatha Natural Roasted Sesame Tahini in 16-oz glass jars (Case UPC 0 51651 26029,
    Item UPC 0 51651 06029) and 32-lb plastic pails (Item# 201S9034), Recall # F-486-7;
b) MaraNatha Natural Raw Sesame Tahini in 16-oz glass jar, Case UPC 0 51651 26028,
    Item UPC 0 51651 06028, Recall # F-487-7;
c) MaraNatha Organic Roasted Sesame Tahini in 16-oz glass jars (Case UPC 0 51651 29226,
    Item UPC 0 51651 09226), 15-lb plastic pails (Item 2019037, Case UPC 09037) and
    32-lb plastic pails (Item 2019038, Case UPC 0 51651 09038), Recall # F-488-7;
d) MaraNatha Organic Raw Sesame Tahini 16 oz. glass jars (Case UPC 0 51651 29225,
    Item UPC 0 51651 09225), in 15-lb plastic pails (Item 2019035, Case UPC 0 51651 09035)
    and in 32-lb plastic pails (Item 2019036, Case UPC 0 51651 09036), Recall # F-489-7;
e) Whole Foods brand 365 Organic Everyday Value Sesame Tahini in 16 oz. glass jars.
    UPC number 0009948240599, Recall # F-490-7
CODE
a), c), and d) "Use by" date of 04/11/08 and earlier. Expiration date of 01/05/08 (lot 07130), and earlier;
b) and e)  "Use by" date of 04/11/08 and earlier;
RECALLING FIRM/MANUFACTURER
Recalling Firm: nSpired Natural Foods, San Leandro, CA, by telephone and press releases on May 23, and May 25, 2007.
Manufacturer: Nspired Natural Foods, Ashland, OR. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
16-oz: 519,540 units; 15-lb: 2,886 units; 32-lb: 2,936 units
DISTRIBUTION
Nationwide, Canada and, Japan 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
DG Guarantee brand PMS Formula, Acetaminophen 500 mg, Pamabrom 25 mg, Pyrilamine maleate 15 mg, 32 CAPLETS bottles, Multi-Symptom Maximum Strength (Premenstrual Symptom Reliever), UPC # 50844 36927, Recall # D-957-2007
CODE
Lots: P40623 (exp. date 5/08), P41407 (exp. date 6/08), P41433 (exp. date 6/08), P41434 (exp. date 6/08), P41764 (exp. date 7/08), P42322 (exp. date 9/08), P42323 (exp. date 9/08), P42425 (exp. date 9/08), P42690 (exp. date 9/08), P42691 (exp. date 9/08), P43379 (exp. date 11/08), P44022 (exp. date 1/09), P44426 (exp. date 2/09), P44778 (exp. date 2/09), P44860 (exp. date 3/09), P44861 (exp. date 3/09), P45752 (exp. date 5/09), P45753 (exp. date 5/09)
RECALLING FIRM/MANUFACTURER
LNK International, Inc., Hauppauge, NY, by letter dated August 6, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled. Directions for use on bottle incorrectly state "adults and children 12 years and over: take 2 caplets with water, repeat every 4 hours as needed..." but should correctly state “repeat every 6 hours”.
VOLUME OF PRODUCT IN COMMERCE
587,232 bottles of 32 caplets
DISTRIBUTION
KY, VA, MS, OH, OK, MO, IN, FL, and SC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

__________________________________
PRODUCT
Source Plasma, Recall # B-1387-07
CODE
Units: 04PWID9915, 04PWIE0397
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Deerfield, IL, by fax on August 18, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information regarding a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1391-07;
b) Platelets, Recall # B-1392-07;
c) Fresh Frozen Plasma, Recall # B-1393-07;
d) Plasma Frozen Cryoprecipitate Reduced, Recall # B-1394-07;
e) Platelets Leukocytes Reduced, Recall # B-1395-07
CODE
a) Units 032KC11962, 032KE26911, 032KE26985, 032KE78325, 032KF73185,
    032KF77699, 032KF83791, 032KM32682, 032KQ48678, 032KQ48783,
    032KQ50697, 032KQ56596, 032KT12914, 032KT12996, 032KT14572,
    032KT14697, and 032KV07140;
b) Units 032GL61122, 032GL73918, 032GL76657, 032KC10116, 032KE15609,
    032KE21519, 032KE22564, 032KE25346, 032KE27198, 032KE27443, 032KE32317,
    032KE39118, 032KE40592, 032KE43732, 032KE53792, 032KF74382, 032KF76327,
    032KF76601, 032KF77445, 032KF82337, 032KF85277, 032KJ46307, 032KJ57813,
    032KJ67668, 032KJ67831, 032KJ69578, 032KJ71946, 032KJ73026, 032KJ75425,
    032KJ77686, 032KL06520, 032KM20236, 032KM20352, 032KM28047,
    032KQ48748, 032KQ50535, 032KQ51773, 032KQ55703, 032KQ56511,  
    032KQ60117, 032KQ64710, 032KQ76385, 032KQ95412, 032KQ96168,
    032KS00644, 032KS01086, 032KY13829, 032KY14115, 032KY18487, and
    032LF39881;
c) Units 032FE99895, 032FT08805, 032GK89412, 032GL63693, 032GL73918,
    032GL76657, 032GL76868, 032GR28938, 032KC10116, 032KC10818, 032KC16110,
    032KC28957, 032KC31594, 032KC31933, 032KE14154, 032KE15609, 032KE21519,
    032KE22564, 032KE27443, 032KE32317, 032KE53792, 032KE57103, 032KE59063,
    032KE59786, 032KE61466, 032KE67785, 032KE67806, 032KE72484, 032KF76327,
    032KF76601, 032KF77445, 032KF84816, 032KF85161, 032KJ57813, 032KJ67668,
    032KJ67831, 032KJ69321, 032KJ69578, 032KJ71946, 032KJ75207, 032KJ75425,
    032KJ77686, 032KJ91002, 032KJ99567, 032KL06520, 032KM35063, 032KN07217,
    032KN07394, 032KN10156, 032KQ46626, 032KQ55703, 032KQ60117,
    032KQ64710, 032KQ95412, 032KR14369, 032KS00644, 032KS01086, 032KT20885,
    032KT26788, 032KY14115, 032KY17968, 032KY17979, 032KY18487,
    032LF39881, 032LL96570, and 032LX27605;
d) Units 032KF77699, 032KT12914, and 032KT12996;
e) Units 032KC31594, 032KE59063, 032KE59786, 032KE67785, 032KE72432,
    032KE72484, 032KN07217, 032KN10048, 032KN10156, 032KN10391,
    032KN21593, 032KT09585, 032KT10862, 032KT26788, 032KV01617, and
    032KV08233
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by telephone or fax on April 2 and 3, 2003, and letter dated April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
152 units
DISTRIBUTION
GA, WI, AL, ID, NC, IL, OH, MA, MI, IA, CA, PR, MN, and NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1396-07
CODE
Unit: 04H65631
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by telephone on January 8, 2007 and by letter dated January 17, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1404-07
CODE
Unit: 1877603
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by fax on November 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1430-07
CODE
Units: 7195822 and 7191732
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 18 and 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1434-07;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1435-07;
c) Platelets Pheresis Leukocytes Reduced Washed, Recall # B-1436-07
CODE
a) Units: 032FT09303, 032FT09304, 032FT09308, 032FT09313, 032FT09314,
    032FT09317, 032FT09317, 032FT09320, 032FT09331, 032FT09339, 032FT09342,
    032FT09343, 02FT09344, 032FT09345, 032FT09347, 032FT09348, 032FT09350,
    032FT09351, 032FT09352, 032FT09355, 032FT09357, 032FT09358, 032FT09360,
    032FT09365, 032FT09367, 032FT09368, 032FT090369, 032FT09373,
    032FT09374,032FT09375, 032FT09384, 032FT09388, 032FT09390, 032FT09396,
    032FT09399, 032FT09401, 032FT09415, 032FT09418, 032FT09448, 032FT09448,
    032FT09454, 032FT09476, 032FT09496, 032FT09511, 032FT09537, 032FT09537,
    032FT09540, 032FT09540, 032FT09568, 032FT09579, 032FT09580, 032FT09585,
    032FT09586, 032FT09586, 032FT09587, 032FT09597, 032FT10405, 032FT10410,  
    032FT10417, 032FT10426, 032FT10433, 032FT10444, 032FT10446, 032FT10463,
    032FT10466, 032FT10466, 032FT10467, 032FT10467, 032FT10471, 032FT10478,
    032FT10478, 032FT10479, 032FT10485, 032FT10486, 032FT10510, 032FT10512,
    032FT10512, 032FT10530, 032FT10530, 032FT10531, 032FT10532, 032FT10545,
    032FT10547, 032FT10553, 032FT10553, 032FT10559, 032FT10559, 032FT10565,
    032FT10584, 032FT10589, 032FT10600, 032FT10602, 032FT10602, 032FT10610,
    032FT10610, 032FT10619, 032FT10625, 032FT10627, 032FT10637, 032FT10637,
    032FT10640, 032FT10640, 032FT10642, 032FT10654, 032FT10654, 032FT10655,
    032FT10657, 032FT10659, 032FT10678, 032FT10679, 032FT10684, 032FT10686,
    032FT10687, 032FT10702, 032FT10716, 032FT10717, 032FT10722, 032FT10722,
    032FT10728, 032FT10734, 032KM38194, 032KM38195, 032KM38196,
    032KM38197, 032KM38197, 032KM38211, 032KM38212, 032KM38252,
    032KM38252, 032KM38271, 032KM38271, 032KM38272, 032KM38319,
    032KM38320, 032KM38334, 032KM38356, 032KM38359, 032KM38406,
    032KM38406, 032KM38416, 032KM38441, 032KM38442, 032KM38443,
    032KM38443, 032KM38455, 032KM38474, 032KM38475, 032KM38480,
    032KM38480, 032KM38497, 032KM38501, 032KM38508, 032KM38518,
    032KM38520, 032KM38522, 032KM38531, 032KM38534, 032KM38569,
    032KM38572, 032KM38593, 032KM38594, 032KM38595, 032KM38595,
    032KM38596, 032KM38596, and 032KM38599;
b) Units: 032FT09325, 032FT09332, 032FT09349, 032FT09370, 032FT09424,
    032FT09456, 032FT09457, 032FT09507, 032FT10405, 032FT10528,
    032FT10558, 032FT10593, 032FT10717, 032FT10738, 032KM38571, and
    032KM38571;
c) Units: 032FT09305, 032FT10482, 032KM38500, and 032KM38535
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
186 units
DISTRIBUTION
IL and WI

___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1448-07
CODE
Units: 6142999 (Part A) and 6142999 (Part B)
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by telephone on July 7, 2005.  Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1455-07
CODE
Units: 6167049, 6167041, 6167045, 6167011, 6167029, 6167032, 6167036, 3240287, 3240337, 6167034, 3240360, 3240362, 1721443, 3240351, 3240334, 3240340, 3240365, 3240342, 3240364, 6167008, 1721441, 3240281, 3240330, 3240286, 3240356, 3240289, 3240336, 3240333, 3240349, and 6167007
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone on November  8, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance with standard operating procedures (SOP), were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1331-07
CODE
Units: 3837230 (split unit)
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone and letter on January 29, 2007. Firm initiated recall is complete.
REASON
Platelets, HLA incompatible with the designated recipient but labeled HLA compatible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
_______________________________
PRODUCT
Source Plasma, Recall # B-1383-07
CODE
Units: I72030362, I72056790, I72041212, I72056969, I72053241, I72035673, I72026220, I72035677, and I72050808
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth, TX, by fax on May 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1384-07
CODE
Units: I72043020, I72035266, 364004672, I72052454, I72043647, I72052144, I72052434, 364004621, I72047356, I72054961, I72041195, 364001990, I72034585, 364001842, I72053858, I72036569, 364003764, 364003693, 364004896, 364000177, I72055055, I72058575, I72056802, I72039771, I72058884, I72050211, I72044745, and I72056290
RECALLING FIRM/MANUFACTURER
International BioResources, Llc., Fort Worth, TX, by fax on June 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007
CODE
Software version 3.0
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing.
REASON
Sample ID and Patient results could be associated with the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide and Belgium
___________________________________
PRODUCT
a) PhaSeal, Protector 14, Item No. P14, US Order No. 21320, Recall # Z-1178-2007;
b) PhaSeal Injector Luer Lock, Model Item N31, US Order No. 10310, Recall # Z-1179-2007;
c) PhaSeal, Protector 21, Item No. P21, US Order No. 22020, Recall # Z-1180-2007;
d) PhaSeal, Protector 50, Item No. P50, US Order No. 22050, Recall # Z-1181-207
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carmel Pharma, Inc., Columbus, OH, by letters on June 15, 2007.
Manufacturer: Carmel Pharma Ab, Gotenburg, Sweden. Firm initiated recall is ongoing.
REASON
Risk of Leakage. When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.
VOLUME OF PRODUCT IN COMMERCE
6.1 million
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and
    Cals B-F (4ml each)-Product List Number-7A73-01, Recall # Z-1185-2007;
b) AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL
    & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing
    quinidine prepared in human serum to yield the different concentration ranges-
    Product List Number 7A73-10, Recall # Z-1186-2007;
c) XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).
    Product List Number-9506-01, Recall # Z-1187-2007;
d) XSYSTEMS Quinidine Controls are composed of 3 bottles of controls
    (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum
    to yield different concentration ranges.-Product List Number 9506-10,
    Recall # Z-1188-2007
CODE
a) Lot # 44794Q100 Exp. Date: 08/09/2007 and
    Lot # 47093Q100 Exp. Date: 10/10/2007;
b) Lot # 43273Q100 Exp. Date: 06/23/2007 and
    Lot # 47028Q100 Exp. Date; 10/14/2007;
c) Lot # 42442Q100 Exp. Date: 07/17/2007,
    Lot # 44791Q100 Exp. Date: 10/09/2007,
    Lot # 46753Q100 Exp. Date: 12/10/2007,
    Lot # 48107Q100 Exp. Date: 10/09/2007,
    Lot # 50236Q100 Exp. Date: 04/21/2008,
    and Lot # 51591Q100 Exp. Date: 04/21/2008;
d) Lot # 44161Q100 Exp. Date: 08/23/2007,
    Lot # 46295Q100 Exp. Date: 8/23/2007,
    Lot # 48239Q100 Exp. Date: 01/04/2008,
    and Lot# 50238Q100 Exp. Date: 05/20/2008
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters beginning May 31, 2007. Firm initiated recall is ongoing.
REASON
Controls Out of Range/Specification.
VOLUME OF PRODUCT IN COMMERCE
719
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BacT/ALERT® FN Culture Bottles, Product Number 259793, Recall # Z-1189-2007
CODE
Lot: 1015145
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on February. Firm initiated recall is ongoing.
REASON
Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
VOLUME OF PRODUCT IN COMMERCE
2,403 cases (100 bottles per case)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm), Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H, Recall # Z-1193-2007
CODE
Lots: B093934202, B093924204, B09324223, B093924225, B093924227, B093924229, B093924233, B093924244, B093924246, B093924248, B093924250, B093924286, B093924288, B093924296, B093924307, B093924309, B093924310, B093924434, B093924476, B093927301, B093927302, B093927322, B300903936
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by telephone on March 22, 2007.
Manufacturer: Steris Mexico, Guadalupe, Mexico. Firm initiated recall is ongoing.
REASON
The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370, Recall # Z-1194-2007
CODE
Lot: 2385941
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated June 25, 2007.
Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is complete.
REASON
The package actually contains a knee patellar implant.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MD
___________________________________
PRODUCT
ABL80 FLEX Analyzer, Model #393-839, Recall # Z-1196-2007
CODE
All analyzers produced between 10/26/06 to 3/15/07 are being recalled (serial code/lot code range of 300101 to 300517)
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by letters on March 27, 2007. Firm initiated recall is ongoing.
REASON
There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.
VOLUME OF PRODUCT IN COMMERCE
334 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

__________________________________
PRODUCT
Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM). Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A, Recall # Z-1190-2007
CODE
All units shipped on or before November 2005
RECALLING FIRM/MANUFACTURER
Volcano Corporation, Rancho Cordova, CA, by letter beginning April 2, 2007. Firm initiated recall is ongoing.
REASON
During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.
VOLUME OF PRODUCT IN COMMERCE
383 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Catalog Model number/Product UPN number M0049663S0, Recall # Z1191-2007
CODE
Batch numbers: 9535942, 9596195, 9618290
RECALLING FIRM/MANUFACTURER
Boston Scientific, Corp., San Jose, CA, by letters on June 26, 2007. Firm initiated recall is ongoing.
REASON
Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
FL and TN
__________________________________
PRODUCT
Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each, Recall # Z-1197-2007
CODE
Lot number 700894M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by telephone and letter on July 11, 2007.
Manufacturer: Alcon Manufacturing LTD, Sinking Spring, PA. Firm initiated recall is complete.
REASON
Mislabeled. Boxes actually contained Tri-Fact needles.
VOLUME OF PRODUCT IN COMMERCE
2 boxes
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINES - CLASS I

__________________________________
PRODUCT
a) Berkley & Jensen Full Cut Pig Ear dog treats, 25 count bag. Sold to BJ’s Wholesale  
    Club, Recall # V-049-2007;
b) Beefeaters Brand: Bulk Low Fat Pig Ears -- Item number 8915, Recall # V-050-2007;
c) Beefeaters Brand: Two Pack Bulk Pig Ears -- Item number 8772P,
    Recall # V-051-2007;
d) Beefeaters Brand: 12 pack Bulk Pig Ears -- Item Number 8770P,
    Recall # V-052-2007;
e) Beefeaters Brand: 24 Pack Bulk Pig Ears -- Item Number 8774P,
    Recall # V-053-2007;
f) Beefeaters Brand: 1 lb. Bulk Pig Ear Strips -- Item number 7416,
    Recall # V-054-2007;
g) Beefeaters Brand: 24 oz. Bulk Pig Ear Strips -- Item number 7425,
    Recall # V-055-2007
CODE
a) BEST IF USED BY 2009, BEST IF USED BY SEPTEMBER 2009,
    BEST IF USED BY OCTOBER 2009, BEST IF USED BY NOVEMBER 2009,
    BEST IF USED BY DECEMBER 2009;
b) Lot numbers: 101808 and 102108.
c) Lot number: 101707;
d) Lot number: 101707;
e) Lot number: 101907;
f) Lot number: 10907;
g) Lot number: 5039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Petra Pet, Inc dba Petrapport, North Bergen, NJ, by press release on March 23, and March 29, 2007 and by letter on March 29, 2007.
Manufacturer: Graneles De Chile S.A., Rancagua, Chile. Firm initiated recall is ongoing.
REASON
Pig ear dog treats may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
132640 bags; 12814 bulk units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR AUGUST 29, 2007

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