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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June 4, 2008
08-23

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

___________________________________
PRODUCT
Grassplot brand Dried Pachyrhizus, Net Wt. 8 oz. (227g). Ingredients: Pachyrhizus, sugar, etc. UPC barcode # 6 920433 006124, Nutrition Facts Serving Size 227 g; Servings Per Container 1. The product is packed in a sealed, flexible plastic bag, Recall # F-353-8
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lion Pavilion Ltd., Brooklyn, NY, by press release and letters on February 15, 2008.
Manufacturer: Grassplot Foodstuff Factory, Shantou, Guangdong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (777 pm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
78 cartons (30-8 oz. bags per carton)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cantaloupes, Mike’s Melons from Honduras. 9 each per carton, Recall # F-354-8
CODE
No code available
RECALLING FIRM/MANUFACTURER
Pero Vegetable Company, Delray Beach, FL, by telephone and e-mail on March 24, 2008. Firm initiated recall is complete.
REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
3,712 cartons
DISTRIBUTION
MN, GA, TX and IL
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PRODUCT
a) Melam Brand of Piriyan Chilly Powder in the following sizes: 200g pouches,
    200g packages and 400g packages; Product of India, Recall # F-355-8;
b) Melam Brand of Coriander Powder in the following sizes: 250g pouches,
    500g pouches, 200g packages and 400g packages; Product of India, Recall # F-356-8
CODE
JN/2008 Date of MFG 1/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grace Supply Inc., Missouri City, TX, by telephone on April 3, 2008.
Manufacturer: M/S M.V.J. Foods (India) Pvt. Ltd., Kochi, India. Firm initiated recall is complete.
REASON
Products found positive for Salmonella Poly Group G.
VOLUME OF PRODUCT IN COMMERCE
1,274 packages
DISTRIBUTION
OK and TX
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PRODUCT
Cantaloupe, Chestnut Hill Farms brand, 40 pound box, 12 cantaloupes/box, or single bag (1 melon) & triple bag (3 melons. The three melons in a sleeve are sold under the brand Chestnut Hill Farms, and one melon per sleeve under the Perfect Melon brand. Individual melons are not labeled, but sleeves contain tags that say either Perfect Melon (one count) or Chestnut Hill Farms, Recall # F-357-8
CODE
All codes
RECALLING FIRM/MANUFACTURER
Bounty Fresh, LLC, Miami, FL, by e-mails on March 22, 2008 and press release on March 27, 2008. Firm initiated recall is ongoing.
REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
37,533 boxes
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Whole Cantaloupe Fruits; carry a "Mike's Melons" sticker or may be unlabeled because this sticker has fallen off. Whole cantaloupe fruits subject to this recall were sold in approximately 1100 pound cardboard bin containers, Recall # F-358-8
CODE
Lot Numbers: 33-35, 38, 39, 42-44, 46-48, 50, 52-54, 59 and 60
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tropifresh Inc., Los Angeles, CA, by telephone on March 24, 2008, press release on March 26, 2008 and by letter on March 27, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is ongoing.
REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
684 bins (342 Pallets containing 2 bins each) = 730,308 lbs
DISTRIBUTION
CA, PA and Canada
___________________________________
PRODUCT
a) Cut cantaloupe in hard plastic clamshell and buckets labeled Cut Cantaloupe Net Wt.
    Product is sold in clamshell containers: 16 oz - 6 per case, 20 lb size sold in buckets,
    Recall # F-359-8;
b) Cantaloupe, honeydew & pineapple in plastic clamshell labeled "Charlie's
    RAINBOW". Product sold in 8 oz - 9 per case and 16 oz - 6 per case,
    Recall # F-360-8;
c) Charlie's cantaloupe, honeydew, pineapple and grapes in plastic clamshell, plastic
    tray, and plastic bucket labeled as "CUT MIXED FRUIT" or "MIXED FRUIT" in 16
    oz - 6 per case & 24 oz - 4 per case clamshell containers, "CHARLIES CUT MIXED
    FRUIT" or 'MIXED FRUIT" in 64 oz. - sold individually in clamshell container,
    "CHARLIES SPOKANE MIXED FRUIT 1/20 #" - sold in 20 lb buckets, "CUT
    FRUIT TRAY" in 40 oz. (8") - 3 per case and 76 oz. (12") - 2 per case in trays,
    "GRAB & GO FRUIT TRAY" in 16 oz. tray, Recall # F-361-8
CODE
Use by date of "03 07" through "03 29" stamped on the bottom of the container.
RECALLING FIRM/MANUFACTURER
Triple B Corporation dba Charlie’s Produce Spokane, Spokane, WA, by telephone and letter on March 22, 2008. Firm initiated recall is complete.
REASON
Cantaloupes used in products were imported from a Honduran firm, and have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
373 units, various sizes
DISTRIBUTION
WA, IA, and MT
___________________________________
PRODUCT
a) Carol's Cuts Cantaloupe Chunks packaged in 8-oz. plastic containers, 6 per case,
    and 5-lb. plastic containers, 2 per case, Recall # F-362-8;
b) Carol's Cuts Fruit Medley, ingredients may contain honeydew, cantaloupe, pineapple,
    grapes, strawberries, packaged in 8-oz. plastic containers, 6 per case, Recall # F-363-8
CODE
Processed on 3/14/08
RECALLING FIRM/MANUFACTURER
Liberty Fruit Co. Inc., Kansas City, KS, by telephone on March 24, 2008. Firm initiated recall is terminated.
REASON
Product was manufactured using cantaloupes imported from a Honduran firm, which have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
Cantaloupe chunks - 5/6/8-oz. plastic container cases and 20/2/5-lb. plastic container cases; Fruit Medley - 150/6/8-oz. container cases
DISTRIBUTION
KS and MO
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PRODUCT
a) Cube Cut Cantaloupe in 5 lb and 22 lb plastic bags with brand name: "Fresh Express
    Foods Corporation, Inc." Recall # F-364-8;
b) Cube Cut Cantaloupe with grapes in 5 lb plastic bags with brand name: "Fresh
    Express Foods Corporation, Inc." Recall # F-365-8
CODE
a) 45845, cubed cantaloupe, 5 lb bag; 49845, cubed cantaloupe 22 lb bag;
b) 45854, cubed melons and grapes 5 lb bag
RECALLING FIRM/MANUFACTURER
Fresh Express Foods Corporation, Medford, OR, by telephone on March 22, 2008. Firm initiated recall is ongoing.
REASON
Products were manufactured using cantaloupes imported from a Honduran firm, which have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
Approximately 195 lbs
DISTRIBUTION
OR
___________________________________
PRODUCT
a) Cut cantaloupe (chunks or pieces) in plastic cups and trays packed under Yoke's brand,
    Rosauers Produce Classic brand and Garden Patch Produce brands. Sizes include
    5 oz., 8 oz, 11 oz., 16 oz, 21 oz, 24 oz, 32 oz, 48 oz, 64 oz, 5 lb, Recall # F-366-8;
b) Melon Medley consisting of cantaloupe, honeydew and watermelon in plastic cups
    and trays packed under Yoke's brand, Rosauers Produce Classic brand and Garden
    Patch Produce brands. Sizes include 6 oz, 8 oz, 11 oz, 16 oz, 23 oz, 24 oz, 32 oz,
    48 oz, 64 oz, Recall # F-367-8;
c) Mixed Melon Can-Hon consisting of cantaloupe and honeydew in plastic cups and
    trays packed under Yoke's brand, Rosauers Produce Classic brand and Garden Patch
    Produce brands. Sizes include 5 oz, 8 oz, 11 oz, 16 oz, 22 oz, 24 oz, 32 oz, 48 oz,
    Recall # F-368-8;
d) Fruit Medley consisting of cantaloupe, honeydew, pineapple, grapes, orange,
    strawberry in plastic cups and trays packed under Yoke's brand, Rosauers Produce
    Classic brand and Garden Patch Produce brands. Sizes include 5 oz, 8 oz, 11 oz,
    16 oz, 23 oz, 24 oz, 32 oz, 48 oz, 64 oz, Recall # F-369-8;
e) Mixed Melon & Fruit consisting of cantaloupe, honeydew, watermelon, kiwi and
    pineapple in plastic cups and trays packed under Yoke's brand, Rosauers Produce
    Classic brand and Garden Patch Produce brands. Sizes include 6 oz, 11 oz, 16 oz,
    24 oz, Recall # F-370-8;
f) Fruit Trays consisting of grapes, cantaloupe, honeydew, watermelon, pineapple in
    plastic trays packed under Yoke's brand, Rosauers Produce Classic brand and
    Garden Patch Produce brands. Sizes include 40 oz, 48 oz, 75 oz, Recall F-371-8
CODE
Best if used by up to and including 03/26/08
RECALLING FIRM/MANUFACTURER
Spokane Products, Inc., Spokane, WA, by telephone on March 22, 2008. Firm initiated recall is complete.
REASON
Cantaloupes associated with Salmonella Litchfield outbreak were used in various cut fruit products.
VOLUME OF PRODUCT IN COMMERCE
10,217 units
DISTRIBUTION
WA, OR, ID, MT, and WY
___________________________________
PRODUCT
a) Cantaloupe Chunks sold in 8lb, 2x8lb, 18lb, 24lb, 32lb, 1x6lb, 3x6lb, or 4x3lb pails
    labeled as: Sun Rich Fresh , SYSCO Imperial, Snoboy Picked for Flavor and Ready
    Set Serve by Markon. A sticker is applied to indicate the type of cut, Recall # F-372-8;
b) Cantaloupe Chunks Diced or Bitesize sold in 8lb, 18lb, 24lb pails labeled as Sun Rich
    Fresh, SYSCO Imperial, and Ready Set Serve by Markon. A sticker is applied to
    indicate the type of cut, Recall # F-373-8;
c) Cantaloupe Spears sold in 8lb and 18lb pails labeled as Sun Rich Fresh and SYSCO
    Imperial. A sticker is applied to indicate the type of cut, Recall # F-374-8;
d) Cantaloupe Halves sold in a 24lb pail labeled as Sun Rich Fresh. A sticker is applied
    to indicate the type of cut, Recall # F-375-8;
e) Cantaloupe/Honeydew/Grapes Mix sold in an 8lb pail labeled as Sun Rich Fresh,
    Recall # F-376-8;
f) Fruit al Fresco or al Fresco Fruit Salad sold in 14lb and 32lb pails labeled as Sun Rich
    Fresh, Recall # F-377-8;
g) Fruit Salad Deluxe sold in 8lb, 2x8lb, 18lb, 24lb, 32lb, 6x4lb pails labeled as Sun
    Rich Fresh, SYSCO Imperial, Winter Garden and Ready Set Serve by Markon,
    Recall # F-378-8;
h) Fruit Salad Deluxe Preservative-Free sold in a 14lb pail labeled as SYSCO Imperial
    or Ready Set Serve by Markon, Recall # F-379-8;
i) Fruit Salad Deluxe Diced sold in 8lb, 2x8lb, 18lb, 24lb pails labeled as Sun Rich
    Fresh, SYSCO Imperial and Ready Set Serve by Markon. A sticker is applied to
    indicate the type of cut, Recall # F-380-8;
j) Malibu Mix sold in 8lb, 18lb, 24lb pails labeled as Sun Rich Fresh and Ready Set
    Serve by Markon, Recall # F-381-8;
k) Tropical Fruit Salad sold in 8lb and 24lb pails labeled as Sun Rich Fresh, Recall # F-
    382-8;
l) Honeydew & Cantaloupe Chunks sold in 2x8lb pails labeled as Sun Rich Fresh,
    SYSCO Imperial and Ready Set Serve by Markon. A sticker is applied to indicate the
    type of cut, Recall # F-383-8;
m) Honeydew & Cantaloupe Balls sold in an 8lb pail labeled as Sun Rich Fresh and
    SYSCO Imperial. A sticker is applied to indicate the type of cut, Recall # F-384-8;
n) Fruit Combo sold in 8lb and 24lb pails labeled as Snoboy Picked For Flavor,
    Recall # F-385-8;
o) Fruit Salad Light Blend sold in 2x8lb pail labeled as SYSCO Imperial,
    Recall # F-386-8
CODE
a) thru o) Lot Codes: 380203, 380303, 380403, 380503, 380903, 381003, 381103, 381603, 381703, 381803, 382402, 382502, 382602, 382802, 481803, 481903, 482003, 482103, 10280703, 10281003, 10281703, 10281803, 10281903, 10282102, 10282103, 10282602, 10282702, 10282802, 10282902, 20280103, 20280703, 20280903, 20281003, 20281703, 20281803, 20282003, 20282103, 20282802, 20282902
RECALLING FIRM/MANUFACTURER
Sun Rich Fresh Foods Inc., Richmond, Canada, by letter dated March 23, 2008 and March 24, 2008. Firm initiated recall is complete.
REASON
Product was processed from cantaloupes imported from a Honduran firm, which have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
59,498 pails
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Whole cantaloupes packed in cardboard cartons with approx 9-12 whole cantaloupes/carton with the brands "Chiquita," "Mayan Pride" and "Mike's Melons" stamped on the side, Recall # F-387-8
CODE
Product not coded.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chiquita Brands International, Inc., Cincinnati, OH, by telephone and letter on March 22, 2008.
Manufacturer: Agropecuaria Montelibano, Choluteca, Honduras. Firm initiated recall is ongoing.
REASON
Cantaloupes imported from a Honduran firm, which have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
126, 248 cases/9-12 cantaloupes
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Whole cantaloupe fruits sold in 40 lb. cardboard cartons (cases) marked with the following text: “Cantaloupe, Mike’s Melons, Produce of Honduras, Recall # F-388-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legend Produce, Phoenix, AZ, by fax and email letters on March 22, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is ongoing.

REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
7,656 cartons
DISTRIBUTION
AZ, CA, HI, OR, UT, WA, and Canada
___________________________________
PRODUCT
Fresh Whole Cantaloupe, received in cases of 12 marked “Mike’s Melons”, “Produce of Honduras” , Recall # F-389-8
CODE
No codes on product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wuhl Shafman Lieberman Corp., Newark, NJ, by telephone on March 22, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is complete.
REASON
Cantaloupes imported from a Honduran firm, have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
2,560 cases. Each case contains 12 cantaloupes
DISTRIBUTION
NJ
___________________________________
PRODUCT
Cubed Cantaloupe, 5 lbs. packaged in 1 gallon clear plastic tubs, Recall # F-390-8
CODE
Date: 3-21-08
RECALLING FIRM/MANUFACTURER
Charlie Sciara & Son Produce Co., Inc., Memphis, TN, by fax on April 10, 2008. Firm initiated recall is complete.
REASON
Cubed cantaloupe was processed from cantaloupes imported from a Honduran firm, which have been associated with an outbreak of Salmonella Litchfield.
VOLUME OF PRODUCT IN COMMERCE
15 tubs
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

___________________________________
PRODUCT
a) Family Dollar Milk of Magnesia Mint Flavor, Magnesium hydroxide 400mg, 12 fl.
    oz. bottles, Recall # D-214-2008;
b) Family Dollar Milk of Magnesia Cherry Flavor, Magnesium hydroxide 400mg, 12 fl.
    oz. Bottles, Recall # D-215-2008
CODE
a) Lot Numbers: 32393, 32394, 32395, 32396, 32711, 32712, 33288, 33289;
b) Lot Numbers: 32354, 32355, 32356, 32360, 32361, 32362, 32713, 32714, 33290,
    33291
RECALLING FIRM/MANUFACTURER
Aaron Industries Inc., Lynwood, CA, by recall notification on May 1, 2008. Firm initiated recall is ongoing.
REASON
Misbranded; dosing instructions for use as a Laxative for children 2 to 5 years incorrectly states 1-3 tablespoons instead of 1-3 teaspoons once a day.
VOLUME OF PRODUCT IN COMMERCE
74,314 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

___________________________________
PRODUCT
Effexor XR Extended-Release Capsules, 150mg, 90 count bottles, Rx Only, NDC 0008-0836-22, Recall # D-219-2008
CODE
Lot: C47303S Exp. Date: August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letter dated April 17, 2008.
Manufacturer: Wyeth Pharmaceuticals Company, Guayama, PR. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance; handwritten ink numbers were placed on the outside of empty capsules shells during the manufacturing process of the bulk capsules.
VOLUME OF PRODUCT IN COMMERCE
21,930 bottles of 90 capsules each
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1373-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1374-08
CODE
a) Units: 5809342 (Split Unit);
b) Units: 7117088; 7044128; 7042063; 9561192; 4051134; 4004264; 5592891
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax and letter beginning on July 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
AR, LA, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1377-08
CODE
Unit: 4065310
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letters dated December 14, 2005 and December 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1411-08
CODE
Unit: 0393945
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on July 3, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1412-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1413-08
CODE
a) and b) Units: 019GY70767
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on June 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, KY
___________________________________
PRODUCT
Platelets, Recall # B-1419-08
CODE
Units: 4430061, 4430066
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on October 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors who may have been at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1422-08
CODE
Unit: 71X468173
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc, Birmingham Region, Birmingham, AL, by facsimile on July 6, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1424-08
CODE
Unit: 30FW31559
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by facsimile on February 21, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1440-08;
b) Cryoprecipitated AHF, Recall # B-1441-08
CODE
a) and b) Units: 27LV18858
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on March 11, 2008 and follow-up letter on March 12, 2008. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV, CA and D.C.
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1443-08
CODE
Unit: 72E07919X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on October 16, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1444-08
CODE
Unit: 71X449054
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc, Birmingham Region, Birmingham, AL, by telephone on July 6, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1445-08
CODE
Unit: 71X304258
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by telephone on February 15, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1446-08
CODE
Unit: 71X353241
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on September 25, 2005. Firm initiated recall is complete.
REASON
Blood product, with a low pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1447-08
CODE
Unit: 71X27411X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on October 4, 2005. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1448-08
CODE
Unit: 71X275781
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1449-08
CODE
Unit: 4447321
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on March 9, 2007. Firm initiated recall is complete.
REASON
Blood product, which failed quality control testing for hemoglobin concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets, Recall # B-1462-08
CODE
Unit: Q83065
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by fax on February 19, 2008. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1463-08
CODE
Unit: 17FR30905
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by letter dated April 7, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was a resident of a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, CA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1464-08;
b) Platelets, Recall # B-1465-08;
c) Recovered Plasma, Recall # B-1466-08
CODE
a), b), and c) Units: 032KL18453
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on March 11, and March 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MA, IL, CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
a) Biocleanse Patellar Tendon Preshaped 10/10mm. Product code 453002; Biocleanse
    Achilles Tendon Preshaped 10mm. Product code 453006; Biocleanse Tibialis
    Posterior Tendon 200mm. Product code 453016; Biocleanse semitendinous
    Tendon 200mm. Product code 453015; Biocleanse Tibialis Posterior Tendon 200mm.
    Product code 453017, Recall # B-1414-08;
b) L-ACSR Cortical Block 6x14x11mm. Product Code 340641, Recall # B-1415-08
CODE
a) Tissue ID #’s: 4113026, 4113025; 4113028, 4113027; 4113031 4113032;
    4113029 4113030 and 4113033;
b) Tissue ID #’s: 4104650 4104655 4104657 4104649 4104651 4104652 4104653
    4104654 4104656
RECALLING FIRM/MANUFACTURER
Regeneration Technologies, Inc., Alachua, FL, by telephone and letters on February 28, 2008. Firm initiated recall is complete.
REASON
Donor Eligibility/Ineligible donor accepted [except as provided in 1271.65(b) Tissue was distributed from a donor for which repeatedly reactive EIA screening tests for HCV and HTLV-1/HTLV-2 were reported.
VOLUME OF PRODUCT IN COMMERCE
18 grafts
DISTRIBUTION
CO, WI, IN, OH, TX, AZ, ID and TN
___________________________________
PRODUCT
Platelets, Pheresis Leukocytes Reduced, Recall # B-1423-08
CODE
Unit: 102911432 (part 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, Scottsdale, AZ, by letter dated November 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1439-08
CODE
Unit: 27LV18858
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on March 11, 2008 and follow-up letter on March 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV, CA and D.C
____________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1442-08
CODE
Units: 29F01245 (Part 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic, Norfolk, VA, by letter on November 1, 2007 and March 19, 2008. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, NC
___________________________________
PRODUCT
Platelets, Pheresis Leukocytes Reduced, Recall # B-1467-08
CODE
Units: GS99017; GS99018 (Split Unit); GS99019; GS99020 (Split Unit); GS99021; GS99022 (Split Unit); GS99023
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, by letter on July 12, 2007 and by telephone on June 14, 2007. Firm initiated recall is complete.
REASON
Blood products, stored at a temperature above the acceptable range, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361, Recall # Z-1137-2008
CODE
Sysco Software Version 2, release 4.1.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated November 28, 207.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional procedure if the user conducts these housekeeping functions at that time.
VOLUME OF PRODUCT IN COMMERCE
9 devices
DISTRIBUTION
CO, MN, NC, NJ and TX

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Recall # Z-0300-2008
CODE
Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Tucson, AZ, by visit on 9/6/07. Firm initiated recall is complete.
REASON
Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide, Japan and France
___________________________________
PRODUCT
Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002, Recall #
Z-1546-2008
CODE
Serial Numbers: 28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345, 28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709, 28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807, 28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014, 28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076, 28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577, 28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339, 28412072602, 29408072073, 28407072007S, 28409030072RF and 28409030077RM
RECALLING FIRM/MANUFACTURER
Lorad, A Hologic, Inc., Danbury, CT, by letter on March 21, 2008. Firm initiated recall is ongoing.
REASON
Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1., Recall # Z-1644-2008
CODE
Model numbers only
RECALLING FIRM/MANUFACTURER
Emageon, Inc., Hartland, WI, by letters on January 9, and January 18, 2008. Firm initiated recall is ongoing.
REASON
Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 4, 2008

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