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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 27, 2010

October 27, 2010                                                                                        10-42

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________

PRODUCT

1) Oatmeal raisin cookies packaged in clear plastic bags, 2 cookies per package. Labeled as "7-Eleven Fresh to Go" "OATMEAL RAISIN COOKIE 2 PACK". The oatmeal raisin cookies are product number 175067, but the product number does not appear on the product label. Recall # F-0063-2011;

 

2) Chocolate Chunk Cookies packaged in clear plastic bags, 2 cookies per package. Labeled as "7-Eleven Fresh to Go" "CHOCOLATE CHUNK COOKIE". The cookies are item number 171102 but the item code does not appear on the product label. Recall # F-0064-2011

CODE

No lot numbers

RECALLING FIRM/MANUFACTURER

Dough Masters, Troy, MI, by visit on September 16, 2010 and by press release on September 17, 2010. Firm initiated recall is ongoing.

REASON

Undeclared walnuts in Oatmeal Raisin Cookies and Chocolate Chunk Cookies.

VOLUME OF PRODUCT IN COMMERCE

499 units

DISTRIBUTION

MI, OH

___________________________________

PRODUCT

Supreme Cream Mamey Bar – UPC 636418002000. Recall # F-0065-2011

CODE

No lot codes

RECALLING FIRM/MANUFACTURER

California Paleta, Santa Fe Springs, CA, by press release, letter and personal visits beginning August 12, 2010. FDA initiated recall is ongoing.

REASON

The Mamey Pulp purchased and used to make the product was implicated in a  salmonella typhi outbreak in several Western States.

VOLUME OF PRODUCT IN COMMERCE

Unknown

DISTRIBUTION

CA

___________________________________

PRODUCT

1) Lemon-Lime Flavor Effervescent Tablets Dietary Supplement, 10 tablets per box, distributed under the following names and labels: (1) AirHealth(TM) - equate label, UPC 6 05388 66178 4; (2) AirHealth(TM) - Meijer label, UPC 7 19283 59047 3; (3) Air Protector(TM) - equaline label, UPC 0 41163 44076 0; (4) Airshield - TopCare label, UPC 0 36800 14551 1; (5) AirShield(TM) - YourLife label, UPC 0 74970 53220 5; (6) AirShield - CVS label, UPC 0 50428 07878 5; (7) AirShield - Longs WELLNESS label, UPC 3 12333 93141 9; (8) AirShield - Trader Darwin's label, UPC 0 00000 88266 8; (9) immune system support - Target label, UPC 0 74990 73220 3. Product Number 53320. Recall # F-0066-2011;

 

2) Orange Flavor Effervescent Tablets Dietary Supplement, 10 tablets per box, distributed under the following names and labels: (1) AirHealth(TM) - equate label, UPC 6 05388 66146 3; (2) AirHealth(TM) - sun mark label, UPC 0 10939 06044 0; (3) AirHealth(TM) - Safeway and Safeway Select labels, UPC 3 21130 78726 6; (4) AirHealth(TM) - Premier Value label, UPC 8 40986 01982 1; (5) AirHealth(TM) - YourLife label, UPC 0 74970 53140 6; (6) Air Protector(TM) - equaline label, UPC 0 41163 43021 1; (7) Airshield(TM) - YourLife label, UPC 0 74970 53140 6; (8) AirShield - CVS label, UPC 0 50428 07877 8, (10 tablets) and UPC 0 50428 09706 9 (Twin Pack - 2 tubes of 10 tablets each); (9) AirShield - Longs Wellness label, UPC 3 12333 93131 0; (10) AirShield - Trader Darwin's label, UPC 0 00000 88267 5; (11) immune system support - Target label, UPC 0 74990 73140 4. Product Number 53140 (10 tablets) and 53142 (Twin Pack - 20 tablets). Recall # F-0067-2011;

 

3) Airshield Effervescent Formula Dietary Supplement, Pink Grapefruit Flavor, 10 Tablets, CVS label, UPC 0 50428 11516 9. Product Number 54320. Recall # F-0068-2011;

 

4) up&up immune system support dietary supplement, lemon-lime flavor, 10 TABLETS, UPC 0 74990 73220 3. Product Number 85322.  Recall # F-0069-2011;

 

5) up&up immune system support dietary supplement, orange flavor, 10 Tablets, UPC 0 74990 73140 4. Product Number 83140. Recall # F-0070-2011;

 

6) Lemon-Lime Flavor Fizz Formula (sticks), Sugar Free, 8 Single Serve Powder Packets, distributed under the following names and labels: (1) AirHealth(TM) - SAFEWAY label, UPC 3 21130 7873 4; (2) Wal-born - Walgreens label, UPC 3 11917 08770 2. Product Number 53710.  Recall # F-0071-2011

CODE

All lots with expiration date 1/31/12 and earlier

RECALLING FIRM/MANUFACTURER

Recalling Firm: NBTY Acquisitions LLC dba Leiner Health Products, Carson, CA, by press release on August 17, 2010 followed by letters.

Manufacturer: Marlyn Nutraceuticals, Inc., Phoenix, AZ. Firm initiated recall is ongoing.

REASON

The products contain undeclared soy (from the selenium chelate raw material).

VOLUME OF PRODUCT IN COMMERCE

Tablets: 5,096, 114 boxes; Sticks: 26,526 boxes (8 sticks per box)

DISTRIBUTION

Nationwide and PR

___________________________________

PRODUCT

Country Eggs, Inc; Large AA Fresh Shell Eggs; Plant Code P1946 OR P1026; 15 Dozen. Plant Codes: P1946 or P1026. Recall # F-0074-2011

CODE

Lot Numbers: 155221,155222, 15523, 155657, 155658

RECALLING FIRM/MANUFACTURER

Recalling Firm: Country Eggs, Inc., Los Angeles, CA, by telephone on August 14, 2010 and by letter on August 17, 2010 and press release on August 19, 2010.

Manufacturer: Quality Egg, Galt, IA. FDA initiated recall is ongoing.

REASON

The eggs have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

7,342 boxes (15 dozen box)

DISTRIBUTION

CA, AZ, NV

_____________________________________

PRODUCT

Large Shell eggs sold in various count containers (6, 12 and 18 count cartons, 21/2 dozen and 5 dozen sleeve, and 15 dozen and 30 dozen bulk case) under the brand names: 1) Albertson's, Grade AA; 2) Sparboe Farms, Grade A; 3) Liborio Market, Grade AA; 4) Shamrock Farms Grade AA; and 5) Glenview Farms. Extra Large Eggs sold in 12 count carton under the following brands 1) Shurfresh, Grade A. EXPANDED 2) Market pantry, Grade A. 3) Sparboe Farms. Recall # F-0075-2011

CODE

Plant number 1167 with Julian Dates 214, 215 and 219. Plant number 1906 with Julian Dates 211 and 218. EXPANDED: Plant number 1906 with Julian Date 219

FIRM/MANUFACTURER

Sparboe Co., Litchfield, MN, by telephone and email on August 16, 2010 and September 2, 2010 and by press release on August 27, 2010 and September 3, 2010. FDA initiated recall is ongoing.    

REASON

Shell eggs were recalled from Wright County Eggs. The eggs have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

109,754 dozen EXPANDED 15,032 dozen

DISTRIBUTION

CO, IA, IL, KS, MN, MT, ND, NE, SD, WY EXPANDED: AR, LA, MO, OK, TX, WI

_____________________________________

PRODUCT

Egg Noodles; fresh frozen egg noodles; packaged in plastic bags, Net Wt. 5 Lbs., 6 bags per case. Recall # F-0076-2011

CODE

All products shipped between 6/12/10 through 8/20/10. There are no codes on the plastic bags or cases.

FIRM/MANUFACTURER

Real Taste Noodle Manufacturer, Inc., Chicago, IL, by letter dated August 31, 2010. FDA initiated recall is ongoing.

REASON

The fresh frozen egg noodles were manufactured using eggs recalled due to potential contamination with Salmonella enteritidis.

VOLUME OF PRODUCT IN COMMERCE

9,000 cases

DISTRIBUTION

CA, IL, KY, WA

_____________________________________

PRODUCT

Large Fresh Shell Eggs distributed as: California Ranch Fresh (CRF) brand 20 and 30 egg overwraps; Alta Dena Dairy, Driftwood Dairy, Hidden Villa Ranch, and Challenge Dairy brands Loose 15 dozen units. Recall # F-0077-2011

CODE

All affected eggs labeled with plant codes p-1026, p-1413, and p-1946 & Julian code dates 209-224.

FIRM/MANUFACTURER

Recalling Firm: Luberski, Fullerton, CA, by telephone on August 14, 2010, and email beginning on August 16, 2010 and by press release on August 20, 2010.

Manufacturer: Quality Egg, Galt, IA. FDA initiated recall is ongoing.

REASON

The recall was initiated because the affected shell eggs were supplied from Wright County Egg of Galt, Iowa and have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

15,764 units (5,016 x 15 dozen, 258 x 20 ct & 10,490 x 30 ct)

DISTRIBUTION

CA, NV, OR

___________________________________

PRODUCT

Large Loose Shell Eggs distributed as: Yucaipa Valley Large 1 dozen; Albertsons Large 1 dozen and 18 ct; Mountain Dairy Large 1 dozen; Farmer's Gems Large 1 dozen; Large Loose foodservice pack (unbranded) 15 dozen & 30 dozen. Plant Numbers: 1156. Recall # F-0078-2011

CODE

Julian Dates: 187 (July 6, 2010), 187 (July 6, 2010), 187 (July 6, 2010), 187 (July 6, 2010), 187 (July 6, 2010)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Norco Ranch - E&M Ranch, Fontana, CA, by telephone and letters beginning on August 20, 2010, and by letters and press release on August 22, 2010.

Manufacturer: Hillandale Farms Of Iowa, New Hampton, IA. FDA initiated recall is ongoing.
REASON

The recall was initiated because specific lots of the shell eggs produced by Hillandale Farms of Iowa have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

81,240 dozen

DISTRIBUTION

CA, NV

___________________________________

PRODUCT

Trafficanda Egg Ranch Fresh Shell Eggs; Medium, Large, X Large, and Jumbo sizes; packaged in 12-egg cartons, 20-egg Over Wrap and 5 Dozen Medium Over Wrap.

Plant Numbers: 1026, 1413, 1720, 1942 and1946. Recall # F-0079-2011

CODE

Julian Dates: 136 to 229

RECALLING FIRM/MANUFACTURER

Recalling Firm: Trafficanda Egg Ranch, Van Nuys, CA, by telephone, fax, and letters on August 19, 2010, and by press release on August 25, 2010.

Manufacturer: Quality Egg, Galt, IA. FDA initiated recall is ongoing.

REASON

The recall was initiated because specific Julian dates of Medium, Large, X Large, and Jumbo Cartons; 5 Dozen Medium Over Wrap and 20 Count Over Wrap of shell eggs produced by Wright County Egg of Galt, Iowa have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

1,080,000 dozen

DISTRIBUTION

CA

___________________________________

PRODUCT

Eggs in 5 dozen carton packs, in the following brands, UPC codes, plant numbers and Julian Dates: -Bayview Large/7-17544-30172-1/P-1686/142 to 149 -Mountain Dairy Medium/0-11110-89969-9/P-1951/193 to 208 -Nulaid Medium/071230-02140-0/P-1095 and P-1951/167 to 174 and 195 to 210 -Sun Valley Medium/6-48065-11432-6/P-1951/195 to 206; -Lucerne Large/0-21130-03155-9/P-1292/139-210; Product Public Reason for Recall # F-0082-2011

CODE

Product was supplied by Wright County Egg and Hillandale of Iowa, thus may be contaminated with salmonella.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Nucal Foods, Inc., Salida, CA, by e-mail on August 14, 2010 and by press release on August 15, 2010.

Manufacturer: Quality Egg LLC Wright County Div Plant 1, Galt IA; 2) Gemperle Farms, Hughson, CA; 3) Rainbow Farms, Denair, CA; 4) Hilmar Processing LLC, Hilmar, CA; 5) Dwight Bell Processing, Atwater, CA. FDA initiated recall is ongoing.

REASON

Product was supplied by Wright County Egg and Hillandale of Iowa, thus may be contaminated with salmonella.

VOLUME OF PRODUCT IN COMMERCE

Unknown

DISTRIBUTION

CA, NV

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________

PRODUCT

Swanson Ultra ZMA, Anabolic Mineral Support Formula, Dietary Supplement, 90 Capsules, item number SWU102. Supplement Facts Serving size: 3 Capsules. Amount Per Serving: Vitamin B-6 USP Other ingredients: Microcrystalline cellulose (plant fiber), gelatin. UPC: 87614-02102. Recall # F-0080-2011

CODE

Lot / Best before: 1737182 / 06-11,175946 / 01-12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Swanson Health Products, Inc., Fargo, ND, by letter beginning February 22, 2010 and telephone beginning February 23, 2010.  

Manufacturer: Kabco Pharmaceuticals, Inc., Amityville, NY. Firm initiated recall is ongoing.

REASON

Dietary Supplement contains excessive amount of zinc.

VOLUME OF PRODUCT IN COMMERCE

2,862 bottles

DISTRIBUTION

Nationwide, and Australia, Brazil, Croatia, Czech Republic, Denmark, Finland, Germany, Jersey, Slovenia, Spain, Sweden, Switzerland, Hong Kong, Hungary, Macedonia, Yugoslavia

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

_____________________________________

PRODUCT

1) Sanders fine chocolates, Traditional Colonial Layer Cake, Yellow batter with Sander's Buttercream icing, Net Wt 2 Lb 6 oz (1.08kg). Recall # F-0072-2011;

 

2) Sanders, Colonial Butter cream Tea Cake, Net Wt 1 Lb 1 oz (482kg). Recall # F-0073-2011

CODE

1) 0106, 0116, 0126, and 0231;

2) 10-115-01, 10-128-01, and 10-135-01

FIRM/MANUFACTURER

Creative Occasions, Inc., Nashville, TN via e-mail on October 5, 2010 and on October 6, 2010. FDA initiated recall is ongoing.

REASON

Hazelnut meal used to decorate cakes was found to contain elevated levels of yeast and mold.

VOLUME OF PRODUCT IN COMMERCE

1,944 cases

DISTRIBUTION

MI, OH

_____________________________________

PRODUCT

Sweet Henry Yellow Peaches in Kay Pak brand 25 lb. carton boxes, Ripeway Brand 22 lb. carton boxes, RPC in 29 lb. plastic containers, and California Tree Brand in 40 lb. Carton boxes (2-20 lb. bags per carton), keep refrigerated. Recall # F-0081-2011

CODE

Lot 302C with run numbers R4102310103, R4102320103, R41023600201, R4102370021, R4102380202, R4102390203, R4102430102, and R4102440202

FIRM/MANUFACTURER

Sun Valley Packing, Reedley, CA, by telephone, e-mail and letters on September 2, 2010 and September 9, 2010. Firm initiated recall is ongoing.  

REASON

FDA sample analysis found 0.750 ppm of propargite, a pesticide with no tolerance levels for peaches per 40 CFR 180.259.

VOLUME OF PRODUCT IN COMMERCE

13,147 cases

DISTRIBUTION

CA, OR, NM, PA, TN, UT, OK, Canada and Mexico

 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________

PRODUCT

Apidra� SoloStar� [insulin glulisine (rDNA origin) injection], 100 units/mL (U-100), packaged in boxes of five 3 mL prefilled pens, Rx only, NDC 0088-2502-05. Recall # D-017-2011

CODE

Lot # 0F151A; Exp 01/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sanofi-Aventis, Bridgewater, NJ, by letters on September 28, 2010 and October 6, 2010.

Manufacturer: Sanofi Aventis Deutschland Gmb-H, Frankfurt am Main, Germany. Firm initiated recall is ongoing.

REASON

Lack of Assurance of Sterility.

VOLUME OF PRODUCT IN COMMERCE

22,044 boxes (5 pre-filled pens/box)

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________

PRODUCT

Platelets Pheresis, Leukocytes Reduced. Recall # B-2420-10

CODE

Unit: 7129833 (Parts A & B)

RECALLING FIRM/MANUFACTURER

Lane Memorial Blood Bank, Eugene, OR, by facsimile on June 14, 2006. Firm initiated recall is complete.
REASON

Blood products, which were labeled as leukoreduced, but had an elevated White Blood Cell count, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

OR

___________________________________

PRODUCT

1) Platelets Leukocytes Reduced. Recall # B- 2535-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2536-10 

CODE

1) Unit: 033FM22480;

2) Units: 033FM22480, 033GM83544

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Farmington, CT, by facsimile on January 21, 2010. 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

3 units

DISTRIBUTION

CT, CA

___________________________________

PRODUCT

Source Plasma. Recall # B-2557-10

CODE

Units: TA2128391; TA2129991; TA2130903; TA2132672; TA2133202; TA2128059

RECALLING FIRM/MANUFACTURER

DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax on July 14, 2010 and by e-mail on August 9, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who received blood transfusion within the last 12 months, were distributed.

VOLUME OF PRODUCT IN COMMERCE

6 units

DISTRIBUTION

UK

___________________________________

PRODUCT

Source Plasma. Recall # B-2585-10

CODE

Units: BG0482275; BG0482447; BG0482837; BG0483030; BG0483355; BG0483882; BG0484074; BG0484622; BG0485042; BG0485371; BG0486525; BG0480343; BG0480539; BG0481382; BG0481732; BG0481020; BG0481936

RECALLING FIRM/MANUFACTURER

Bowling Green Biologicals LLC, Bowling Green, KY, by facsimile on July 14, 2010 and by e-mail on August 9, 2010. 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

17 units

DISTRIBUTION

CA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2586-10

CODE

Unit: 13FF71046

RECALLING FIRM/MANUFACTURER

American Red Cross Southeastern Michigan Region, Detroit, MI, by facsimile and electronic notification on May 27, 2010 and by letters dated May 27, 2010 and July 7, 2010. 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

CA, MO

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2588-10

CODE

Unit: 21LL19744

RECALLING FIRM/MANUFACTURER

American National Red Cross, Portland, OR, by facsimile on June 19, 2010. 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

CA, WA

_____________________________________

PRODUCT

Source Plasma. Recall # B-2599-10

CODE

Unit: # 3370052025

FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., Fayetteville, NC, by facsimile on August 6, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who was illiterate, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

_____________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2604-10

CODE

Unit: 53FM10099

FIRM/MANUFACTURER

American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on June 24, 2010. Firm initiated recall is complete.

REASON

Blood product, which was labeled as JK(b-), but was collected from a donor who subsequently tested JK(b+), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

DC

_____________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2605-10

CODE

Unit: W038610800748

FIRM/MANUFACTURER

Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax on July 16, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

FL

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # 2606-10

CODE

Unit: W117010177457

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Centers Of The Pacific – Irwin Center, San Francisco, CA, by telephone on July 14, 2010 and by letter on July 23, 2010.

Manufacturer: Blood Centers Of The Pacific – Redwood City Center, Redwood City, CA, Firm initiated recall is complete.
REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

Cryoprecipitated AHF. Recall # B-2607-10

CODE

Unit: 011GF64605

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by fax and letter on May 27, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

France, OK

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2610-10

CODE

Unit: 01Q20954

RECALLING FIRM/MANUFACTURER

The American National Red Cross, West Henrietta, NY, by fax and email on June 28, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA, CT

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2613-10

CODE

Unit: W045110164981

RECALLING FIRM/MANUFACTURER

Community Blood Center of the Ozarks, Springfield, MO, by e-mail on June 21, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Austria

___________________________________

PRODUCT

1) Red Blood Cells. Recall # B-2630-10;

2) Platelets. Recall # B-2631-10

CODE

1) and 2) Unit: W287709002378

RECALLING FIRM/MANUFACTURER

LifeSource, Glenview, IL, by facsimile on June 11, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who emigrated from an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

IL

_____________________________________

PRODUCT

Source Plasma. Recall # B-2634-10

CODE

Units: 6140368881; 6140367962; 6140367680; 6140365932; 6140365370

FIRM/MANUFACTURER

CSL Plasma, Evansville, IN, by fax on June 11, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor whose physical exam was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION

NC

_____________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-2638-10;

2) Platelets Pooled Leukocytes Reduced. Recall # B-2639-10

CODE

1) Unit: W051710104357;

2) Unit: W051710802906

FIRM/MANUFACTURER

Rhode Island Blood Center, Providence, RI, by letter dated June 11, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

RI, CT

_____________________________________

PRODUCT

Red Blood Cells. Recall $ B-2640-10

CODE

Unit: W038109059133

FIRM/MANUFACTURER

Recalling Firm: Florida’s Blood Centers, Inc., Port Charlotte, FL, by letter dated June 30, 2010.

Manufacturer: Florida’s Blood Centers, Inc., Cape Coral, FL. 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

FL

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2641-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2642-10;

3) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-2643-10;

4) Red Blood Cells. Recall # B-2644-10

CODE

1) Unit: W141609479880;

2) Unit: W141609478296;

3) Units: W141609479880, W141609476321;

4) Unit: W141609476321

RECALLING FIRM/MANUFACTURER

Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated April 1, 2010.

Manufacturer: Puget Sound Blood Center and Program, Everett, WA. Firm initiated recall is complete.
REASON

Blood products, collected from a donor who reported travel to an area potentially endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

5 units

DISTRIBUTION

CA, WA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2646-10

CODE

Unit: 2475975

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 23, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

KY

___________________________________

PRODUCT

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2647-10;

2) Platelets Pheresis Leukocytes Reduced. Recall # B-2648-10

CODE

1) and 2) Unit: W0416100156201

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems, Inc. /dba United Blood Services, Meridian, MS, by telephone on June 5, 2010 and August 10, 2010, by fax on June 10, 2010 and letter dated July 2, 2010.

Manufacturer: Blood Systems, Inc. /dba United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who engaged in high risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

MS, TX

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2649-10

CODE

Unit: W038210056055

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on June 2, 2010. Firm initiated recall is complete.

REASON

Blood product, possibly contaminated with air during collection, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

KY

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2650-10

CODE

Unit: 3377929

RECALLING FIRM/MANUFACTURER

Florida’s Blood Centers – Lake Park, Lake Park, FL, by e-mail on July 8, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

Austria

_____________________________________

PRODUCT

Recovered Plasma. Recall # B-2651-10

CODE

Unit: W229810503514

FIRM/MANUFACTURER

Blood Center of Northcentral of Wisconsin, Inc., Wausau, WI, by fax on August 3, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who received an accidental needlestick within 3 months of donating, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NY

_____________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-2652-10;

2) Fresh Frozen Plasma. Recall # B-2653-10

CODE

 1) and 2) Unit: 5000491

FIRM/MANUFACTURER

Atlanta Blood Services, Atlanta, GA, by telephone on February 15, 2010 and follow up letter dated February 18, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor with a history of hepatitis A, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

GA

_____________________________________

PRODUCT

Cornea. Recall # B-2677-10

CODE

Units: 20080275, 20080276

FIRM/MANUFACTURER

Wichita Eye Foundation, Wichita, KA, by telephone on March 24, 2008 and a follow up letter on April 1, 2008. Firm initiated recall is complete.

REASON

Human Corneas, recovered from a donor with a Reactive RPR test, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 corneas

DISTRIBUTION

TX, Egypt

___________________________________

PRODUCT

1) Cryoprecipitated AHF, Pooled. Recall # B-2678-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2680-10

CODE

1) and 2) Unit: 06GS39444

RECALLING FIRM/MANUFACTURER

The American National Red Cross, Pomona, CA, by telephone on June 8, 2010. 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

AZ, CA

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-2682-10;

2) Fresh Frozen Plasma. Recall # B-2683-10;

3) Platelets. Recall # B-2684-10

CODE

1), 2) and 3) Unit: 3778458

RECALLING FIRM/MANUFACTURER

Gulf Coast Regional Blood Center, Houston, TX, by fax on May 21, 24, and 26, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor with an active deferral for a tattoo, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

NJ, TX

___________________________________

PRODUCT

1) Red Blood Cells Leukocytes Reduced. Recall # B-2685-10;

2) Fresh Frozen Plasma. Recall # B-2686-10;

3) Platelets. Recall # B-2687-10

CODE

1), 2) and 3) Unit: W035210062685K

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by telephone on June 22, 2010 and by follow-up letter on July 19, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

TX

_____________________________________

PRODUCT

Red Blood Cells. Recall # B-2688-10

CODE

Unit: W089209016636

FIRM/MANUFACTURER

Sanford Medical Center (Blood Bank), Sioux Falls, SD, by fax on June 18, 2010 and by follow-up letter on July 30, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

SD

_____________________________________

PRODUCT

Source Plasma. Recall # B-2696-10

CODE

Units: 367015842, 367015528, 367014235

FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., Eugene, OR, by facsimile on September 27, 2006. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who did not have a physical examination, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

NC

_____________________________________

PRODUCT

1) Cryoprecipitated AHF. Recall # B-2710-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2712-10

CODE

1) and 2) Unit: 011GW95206

FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by facsimile and letter on June 1, 2010. 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

IL, MO, CA

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2713-10

CODE

Unit: 12KX18214 (split unit)

RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, Charlotte, NC, by facsimile on July 2, 2010 and letter on July 8, 2010 and August 19, 2010.

Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.
REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

GA, NC

___________________________________

PRODUCT

1) Blood Products - Other Platelets Pooled Leukocytes Reduced Irradiated Plasma Reduced. Recall # B-2715-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2716-10

CODE

1) and 2) Unit: W141610551040

RECALLING FIRM/MANUFACTURER

Puget Sound Blood Center and Program, Seattle, WA, by letter dated June 1, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA, WA

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2421-10

CODE

Units: W036810187238; W036810187237; W036810179556

RECALLING FIRM/MANUFACTURER

Community Blood Centers/South Florida, Inc., Lauderhill, FL, by telephone on July 19, 2010. Firm initiated recall is complete.

REASON

Blood products, labeled with an incorrect expiration date, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

FL

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2534-10

CODE

Unit: 033FM22480

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Farmington, CT, by facsimile on January 21, 2010. 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

CT, CA

___________________________________

PRODUCT

Source Plasma. Recall # B-2540-10

CODE

Units: 4270344682; 4270346789

RECALLING FIRM/MANUFACTURER

CSL Plasma, Inc., Tempe, AZ, via the internet on July 12, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

IL

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2556-10

CODE

Unit: 36FK52418

RECALLING FIRM/MANUFACTURER

Recalling Firm: American National Red Cross, Columbia, SC, by fax on April 3, 2010 and electronic mail dated May 21, 2010.

Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. 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

SC

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2587-10

CODE

Unit: 13FF71046

RECALLING FIRM/MANUFACTURER

American Red Cross - Southeastern Michigan Region, Detroit, MI, by facsimile and electronic notification on May 27, 2010 and by letters dated May 27, 2010 and July 7, 2010. 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

CA, MO

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2589-10

CODE

Unit: 21LL19744

RECALLING FIRM/MANUFACTURER

American National Red Cross, Portland, OR, by facsimile on June 19, 2010. 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

CA, WA

___________________________________

PRODUCT

1) Fresh Frozen Plasma. Recall # B-2600-10;

2) Red Blood Cells. Recall # B-2601-10

CODE

1) Units: W127810130080, N23289;

2) Units: W127810130080, W127809503425, W43557, N23289

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and letter on July 16, 2010. Firm initiated recall is complete.

REASON

Blood products, which were collected from an individual who admitted to receiving clotting factor concentrates, were distributed.

VOLUME OF PRODUCT IN COMMERCE

6 units

DISTRIBUTION

WA

_____________________________________

PRODUCT

1) Red Blood Cells. Recall # B-2602-10;

2) Plasma Frozen within 24 hours (FP24). Recall # B-2603-10

CODE

1) Unit: 004X60784;

2) Unit: 004X60810

FIRM/MANUFACTURER

Recalling Firm: Arc Blood Services, New England Region, Dedham, MA, by telephone on April 6, 2010 and by letter on June 21, 2010.

Manufacturer: American Red Cross Blood Services, Worcester, MA. Firm initiated recall is complete.

REASON

Blood products, manufactured from units of whole blood that lacked assurance of proper storage temperature, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

NY, MA

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2608-10

CODE

Unit: 011GF64605 (part a and b)

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by fax and letter on May 27, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

France, OK

_____________________________________

PRODUCT

Source Plasma. Recall # B-2609-10

CODE

Unit: 3980075399

FIRM/MANUFACTURER

International BioResources, LLC, Little Rock, AR, by fax on August 04, 2010. Firm initiated recall is complete.

REASON

Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2611-10

CODE

Unit: 01Q20954

RECALLING FIRM/MANUFACTURER

The American National Red Cross, West Henrietta, NY, by fax and email on June 28, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA, CT

_____________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2612-10

CODE

Unit: 021LV54548

FIRM/MANUFACTURER

American National Red Cross, Portland, OR, by fax on June 3, 2010. Firm initiated recall is complete.

REASON

Blood product, that was not quarantined after receiving information concerning post-donation information, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MS

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2628-10

CODE

Unit: 6043935

RECALLING FIRM/MANUFACTURER

Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on May 4, 2005. Firm initiated recall is complete.
REASON

Blood product, which was below the acceptable limit for red cell recovery, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AK

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2632-10

CODE

Unit: 011LR32452

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by facsimile on July 20, 2010 and letter on July 23, 2010. Firm initiated recall is complete.

REASON

Blood product, prepared without the appropriate amount of additive (ADSOL), was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MO

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2633-10

CODE

Unit: 011KK45390

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by facsimile on June 28, 2010 and by letter on June 30, 2010. Firm initiated recall is complete.

REASON

Blood product, manufactured without the entire quantity of additive solution, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MO

___________________________________

PRODUCT

Source Plasma. Recall # B-2635-10

CODE

Unit: PQ078706

RECALLING FIRM/MANUFACTURER

Plasma Biological Services, Inc., Saint Joseph, MO, by fax on May 12, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT

1) Plasma Frozen within 24 hours (FP24). Recall # B-2636-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-2637-10

CODE

1) and 2) Unit: 9589037

RECALLING FIRM/MANUFACTURER

Florida's Blood Centers, Inc., Orlando, FL, by telephone and letter on November 23, 2009. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who reported taking antibiotics, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

FL

_____________________________________

PRODUCT

Recovered Plasma. Recall # B-2654-10

CODE

Unit: 03R60784

FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by letters dated June 28, 2010 and June 30, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

 

___________________________________

PRODUCT

Recovered Plasma. Recall # B-2679-10

CODE

Unit: 06GS39444

RECALLING FIRM/MANUFACTURER

The American National Red Cross, Pomona, CA, by telephone on June 8, 2010. Firm initiated recall is complete.
REASON

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AZ, CA

_____________________________________

PRODUCT

Recovered Plasma. Recall # B-2681-10

CODE

Unit: 06GL99208

FIRM/MANUFACTURER

The American National Red Cross, Pomona, CA, by letter on June 4, 2010.  Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

_____________________________________

PRODUCT

Recovered Plasma. Recall # B-2711-10

CODE

Unit: 011GW95206

FIRM/MANUFACTURER

American Red Cross Blood Services, Saint Louis, MO, by facsimile and letter on June 1, 2010. 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

IL, MO, CA

_____________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-2717-10

CODE

Unit: 4384042

FIRM/MANUFACTURER

Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated January 31, 2007. Firm initiated recall is complete.

REASON

Blood product, out of controlled storage for an indeterminable length of time, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

 

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________

PRODUCT

iBOT 4000 Mobility System Battery pack. Recall # Z-1775-2010

CODE

Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s) Revision 2.0. Serial number contains the month/year of manufacture followed by a sequential number.

RECALLING FIRM/MANUFACTURER

Independence Technology LLC, Warren, NJ, by letters on February 22, 2010. Firm initiated recall is complete.

REASON

A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.

VOLUME OF PRODUCT IN COMMERCE

192 devices

DISTRIBUTION

Nationwide and the UK

_____________________________________

PRODUCT

1) i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1791-2010;

 

2) i-STAT CG8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1792-2010;

 

3) i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1793-2010;

 

4) i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1794-2010;

 

5) i-STAT EC8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1795-2010;

 

6) i-STAT 6+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1796-2010;

 

7) i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1797-2010;

 

8) i-STAT E3+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen. Recall # Z-1798-2010

CODE

1) List # 03M88-01, 02;

2) List # 03M86-01, 02

3) List # 06F01-01, 02;

4) List # 06F02-01, 02;

5) List # 06F04-01, 02;

6) List # 06F05-01, 02;

7) List # 06F07-01, 02;

8) List # 06F08-01, 02

FIRM/MANUFACTURER

Abbott Point of Care Inc., Princeton, NJ, by letters dated January 2010 and February 5, 2010. Firm initiated recall is ongoing.

REASON

Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

VOLUME OF PRODUCT IN COMMERCE

14,660,925 cartridges

DISTRIBUTION

Nationwide and Internationally

_____________________________________

PRODUCT

GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. Recall # Z-1801-2010

CODE

Parent SN : SED09451341GA SED09471459GA SED09471460GA SED09471461GA SED09471463GA SED09471464GA SED09471467GA SED09471468GA SED09471469GA SED09471470GA SED09471472GA SED09471474GA SED09471476GA SED09471480GA SED09471481GA SED09471486GA SED09471488GA SED09471491GA SED09471493GA SED09471496GA SED09471478GA SED09491583GA SED09491587GA SED09491595GA SED09491596GA SED09491597GA SED09491599GA SED09511674GA SED09511676GA SED10021713GA SED09310446GA SED09310448GA SED09310452GA SED09310453GA SED09310454GA SED09310456GA SED09310458GA SED09310461GA SED09310462GA SED09310468GA SED09310470GA SED09310477GA SED09310496GA SED09310498GA SED09310524GA SED09310525GA SED09320526GA SED09320527GA SED09320529GA SED09320530GA SED09320531GA SED09320532GA SED09320533GA SED09320534GA SED09320535GA SED09320536GA SED09320537GA SED09320539GA SED09320541GA SED09320542GA SED09320543GA SED09320545GA SED09320546GA SED09320547GA SED09320548GA SED09320549GA SED09320550GA SED09330585GA SED09340662GA SED09340663GA SED09370799GA SED09370802GA SED09370803GA SED09370804GA SED09370805GA SED09370806GA SED09370809GA SED09370811GA SED09370812GA SED09370813GA SED09370814GA SED09370815GA SED09370817GA SED09370819GA SED09370820GA SED09370821GA SED09370822GA SED09370825GA SED09370826GA SED09370827GA SED09370828GA SED09370829GA SED09370832GA SED09370833GA SED09390834GA SED09390835GA SED09390836GA SED09390838GA SED09390839GA SED09390840GA SED09390841GA SED09390842GA SED09390843GA SED09390847GA SED09390856GA SED09390857GA SED09390860GA SED09390874GA SED09390876GA SED09390877GA SED09390879GA SED09390882GA SED09390883GA SED09390890GA SED09400894GA SED09400896GA SED09400941GA SED09400945GA SED09400948GA SED09410954GA SED09420980GA SED09420990GA SED09420992GA SED09421001GA SED09451339GA SED09451340GA SED09451342GA SED09451344GA SED09451345GA SED09451346GA SED09451348GA SED09451369GA SED09471432GA SED09471462GA SED09471477GA SED09471494GA SED09491589GA SED09491592GA SED09491600GA SED09491601GA SED09491603GA 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FIRM/MANUFACTURER

Recalling Firm: GE Healthcare, LLLC, Waukesha, WI, letter dated April 22, 2010.

Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing. 

REASON

GE Healthcare has become aware of a safety issue associated with the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue includes the potential for a delay in treatment.

VOLUME OF PRODUCT IN COMMERCE

798 units

DISTRIBUTION

CO, MA, NC, WI, and United Kingdom, Switzerland, Sweden, Spain, Singapore, Portugal, Norway Netherlands, Italy, India, Germany, France, Finland, Belgium, and Australia

___________________________________

PRODUCT

i-STAT PT/INR Cartridge. Catalog numbers: 04J50-01, 04J50-02. Recall # Z-1996-2010

CODE

Lot numbers: N09315, exp 4/28/2010; N09323, exp 5/14/2010; N09323A, exp 5/14/2010; N09346A, exp 5/28/2010; S09347, exp 5/28/2010; S09354, exp 6/14/2010; T10009, exp 6/28/2010; T10011, exp 6/28/2010

RECALLING FIRM/MANUFACTURER

Abbott Point of Care Inc., Princeton, NJ, by letters on May 13 2010. Firm initiated recall is ongoing.

REASON

A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.

VOLUME OF PRODUCT IN COMMERCE

48,624 units

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT

PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems. Recall # Z-1997-2010

CODE

Serial N0. Last 4 Mfg Date 1 A7582075 2075 Aug. 2007 2 A7582079 2079 Aug. 2007 3 A7622164 2164 Feb. 2007 4 A7582081 2081 Aug. 2007 5 A7582068 2068 Aug. 2007 6 A8512207 2207 Jan. 2008 7 A8582246 2246 Aug. 2008 8 A8572233 2233 Jul. 2008 9 A7582069 2069 Aug. 2007 10 A8512206 2206 Jan. 2008 11 A8572230 2230 Jul. 2008 12 A8512202 2202 Jan. 2008 13 A7582067 2067 Aug. 2007 14 A8512194 2194 Jan. 2008 15 A7582065 2065 Aug. 2007 16 A7622167 2167 Feb. 2007 17 A7622168 2168 Feb. 2007 18 A8512191 2191 Jan. 2008 19 A8512211 2211 Jan. 2008 20 A8572245 2245 Jul. 2008 21 A8582251 2251 Aug. 2008 22 A8582252 2252 Aug. 2008 23 A8512208 2208 Jan. 2008 24 A8512210 2210 Jan. 2008 25 A8572235 2235 Jul. 2008 26 A8572234 2234 Jul. 2008 27 A7582085 2085 Aug. 2007 28 A7582078 2078 Aug. 2007 29 A7582071 2071 Aug. 2007 30 A7582086 2086 Aug. 2007 31 A7582087 2087 Aug. 2007 32 A7582088 2088 Aug. 2007 33 A8512203 2203 Jan. 2008 34 A8572236 2236 Jul. 2008 35 A8572237 2237 Jul. 2008 36 A9512321 2321 Jan. 2009 37 A8572231 2231 Jul. 2008 38 A8582249 2249 Aug. 2008 39 A8582248 2248 Aug. 2008 40 A9562441 2441 Jun. 2009 41 A9562442 2442 Jun. 2009 42 A9562443 2443 Jun. 2009 43 A8512209 2209 Jan. 2008 44 A8512195 2195 Jan. 2008 45 A8582247 2247 Aug. 2008 46 A7582066 2066 Aug. 2007 47 A7582072 2072 Aug. 2007 48 A7582073 2073 Aug. 2007 49 A7582076 2076 Aug. 2007 50 A8512205 2205 Jan. 2008 51 A7582070 2070 Aug. 2007 52 A7582080 2080 Aug. 2007 53 A7582082 2082 Aug. 2007 54 A8512204 2204 Jan. 2008 55 A8512201 2201 Jan. 2008 56 A7582083 2083Aug. 2007

RECALLING FIRM/MANUFACTURER

Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on January 5, 2010.

Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

REASON

Toshiba America Medical Systems is initiating a field correction on the PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems due to an incorrect sweep direction setting. Images acquired using the endo-cavitary transducer PVT-681MV and cross-sectional images created from these volume images are reversed horizontally on the Aplio XG (SSA-790A) and the Xario XG (SSA- 680A) diagnostic ultrasound systems.

VOLUME OF PRODUCT IN COMMERCE

27 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

1) Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912. Recall # Z-1999-2010;

 

2) Microstream NIVLINE ADULT 25UN Part Number: 008174. Recall # Z-2000-2010;

 

3) Microstream CAPNOLINE H ADULT 25UN Part Number: 008177. Recall # Z-2001-2010;

 

4) Microstream CAPNOLINE H O2 ADULT 25UN Part Number: 008180. Recall # Z-2002-2010;

 

5) Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Physio Control. Recall # Z-2003-2010;

 

6) Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control. Recall # Z-2004-2010;

 

7) Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826. Recall # Z-2005-2010;

 

8) Microstream SMART CAPNOLINE PLUS 100 UN Part Number: 010209 Oridion 3012176-111 Physio Control. Recall # Z-2006-2010;

 

9) Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio Control. Recall # Z-2007-2010;

 

10) Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433. Recall # Z-2008-2010;

 

11) Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625. Recall # Z-2009-2010;

 

12) Microstream FILTERLINE SET ADULT/PEDIATRIC 100 UN Part Number: 010579-01. Recall # Z-2010-2010;

 

13) Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN Part Number: 010580-01. Recall # Z-2011-2010;

 

14) Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion XS04661 Physio Control. Recall # Z-2012-2010;

 

15) Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341. Recall # Z-2013-2010;

 

16) Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN Part Number: 010343 010341 Part Number: 10341. Recall # Z-2014-2010

CODE

Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009

RECALLING FIRM/MANUFACTURER

Oridion Medical 1987 Ltd., Jerusalem, Israel, by letter on May 26, 2010. Firm initiated recall is ongoing.

REASON

The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.

VOLUME OF PRODUCT IN COMMERCE

19, 377 boxes

DISTRIBUTION

AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI

_____________________________________

PRODUCT

Advantage Turbo 2-Button Shaver. Rx Only, Made In USA, Non Sterile. Catalog Number D9924. This issue has been isolated to products manufactured between June 7, 2004 and June 1, 2006. Recall # Z-2026-2010

CODE

Lot Number: 00001000 00001023 00001024 00001025 00001026 00001027 00001028 00001029 00001030 00001022 00001031 00001032 00001033 00001034 00001035 00001036 00001037 00001038 00001039 00001040 00001041 00001043 00001042 00001044 00001045 00001046 00001047 00001048 00001050 00001051 00001052 00001049 00001053 00001054 00001055 00001056 00001057 00001058 00001059 00001060 00001062 00001063 00001064 00001065 00001061 00001066 00001067 00001068 00001069 00001070 00001071 00001072 00001073 00001074 00001075 00001076 00001077 00001078 00001079 00001080 00001081 00001082 00001083 00001084 00001085 00001086 00001087 00001088 00001089 00001090 00001091 00001096 00001098 00001099 00001100 00001101 00001102 00001103 00001104 00001105 00001106 00001107 00001108 00001097 00001109 00001110 00001111 00001112 00001114 00001115 00001116 00001117 00001118 00001119 00001120 00001121 00001122 00001113 00001123 00001124 00001125 00001126 00001127 00001129 00001130 00001128 00001131 00001132 00001133 00001134 00001135 00001136 00001137 00001138 00001139 00001140 00001141 00001142 00001143 00001144 00001145 00001146 00001147 00001148 00001149 00001150 00001151 00001152 00001153 00001154 00001155 00001156 00001157 00001158 00001160 00001161 00001162 00001163 00001164 00001165 00001166 00001167 00001168 00001169 00001170 00001171 00001172 00001173 00001174 00001175 00001176 00001177 00001159 00001178 00001179 00001180 00001181 00001182 00001183 00001185 00001186 00001187 00001188 00001189 00001190 00001191 00001192 00001193 00001194 00001195 00001196 00001197 00001198 00001200 00001201 00001202 00001203 00001204 00001205 00001206 00001207 00001208 00001209 00001210 00001211 00001212 00001213 00001214 00001216 00001215 00001217 00001218 00001219 00001220 00001221 00001222 00001223 00001224 00001225 00001226 00001227 00001228 00001229 00001230 00001231 00001232 00001233 00001235 00001234 00001236 00001237 00001238 00001239 00001240 00001241 00001242 00001243 00001244 00001245 00001246 00001247 00001248 00001249 00001250 00001252 0001251 00001184 00001253 00001254 00001255 00001256 00001257 00001258 00001260 00001261 00001263 00001264 00001265 00001266 00001267 00001199 00001259 00001262 00001268 00001269 00001270 00001271 00001272 00001273 00001274 00001276 00001275 00001277 00001278 00001279 00001280 00001281 00001282 00001283 00001284 00001285 00001286 00001287 00001288 00001289 00001290 00001291 00001292 00001293 00001294 00001295 00001296 00001297 00001298 00001299 00001300 00001301 00001302 00001303 00001304 00001305 00001306 00001307 00001309 00001310 00001311 00001312 00001313 00001314 00001315 00001316 00001308 00001317 00001318 00001319 00001320 00001321 00001322 00001323 00001324 00001325 00001326 00001327 00001328 00001329 00001330 00001331 00001332 00001333 00001334 00001335 00001336 00001337 00001338 00001339 00001340 00001341 00001342 00001343 00001344 00001345 00001346 00001347 00001348 00001349 00001350 00001351 00001352 00001353 00001355 00001354 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FIRM/MANUFACTURER

Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter on October 29, 2009. Firm initiated recall is ongoing.

REASON

These products may self-activate due to moisture intrusion into the housing body.

VOLUME OF PRODUCT IN COMMERCE

2,373 of which 493 are subject to recall

DISTRIBUTION

Nationwide, United Arab Emirates, Argentina, Australia, Belgium, Switzerland, Chile, China, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, Lithuania, Morocco, Netherlands, New Zealand, Singapore, Turkey, South Africa

___________________________________

PRODUCT

1) GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: IVD. 15/pk. 06260061600. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory. Recall # Z-2107-2010;

 

2) GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory. Recall # Z-2108-2010

CODE

1) Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011;

 

2) Lot # F9GC2001, Exp. 12/31/2010; and L9GC2002, Exp. 5/31/2011

RECALLING FIRM/MANUFACTURER

Recalling Firm: International Technidyne, Corp., Piscataway, NJ, by letters dated July 1, 2010.

Manufacturer: International Technidyne, Corp., Edison, NJ. Firm initiated recall is ongoing.
REASON

Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.

VOLUME OF PRODUCT IN COMMERCE

279 kits

DISTRIBUTION

International Distribution Only -- Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, Switzerland, and Canada

___________________________________

PRODUCT

IMPAX CV Results Manager/Results Manager Administration Tool. Model No. L9M2100. Recall # Z-2112-2010

CODE

Software Versions RM 2.08.12.00.00

RECALLING FIRM/MANUFACTURER

Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 11, 2010.

Manufacturer: AGFA Healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.
REASON

Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended for use in the hospital environment and operating room. Recall # Z-2113-2010

CODE

Serial numbers: DOMESTIC - siri-001852, siri-002292, SIRI-002081, SIRI-002082, SIRI-002085, SIRI-002089, SIRI-002091, SIRI-002097, SIRI-002099, SIRI-002101, SIRI-002102, SIRI-001851, SIRI-001818, SIRI-001819, SIRI-001821, SIRI-001822, SIRI-001823, SIRI-001824, SIRI-001825, SIRI-001826, SIRI-001827, SIRI-001828, SIRI-001829, SIRI-002106, and SIRI-002108. INTERNATIONAL - siri-001861, siri-001853, siri-001855, siri-001857, SIRI-001905, SIRI-002363, SIRI-001948, SIRI-001949, SIRI-001950, SIRI-001951, SIRI-001952, SIRI-001846, SIRI-001847, SIRI-001848, SIRI-001849, SIRI-001921, SIRI-001961, SIRI-001963, SIRI-001964, siri-002139, SIRI-002162, SIRI-002298, SIRI-002349, SIRI-002354, SIRI-001611, SIRI-001612, SIRI-001614, SIRI-001615, SIRI-001616, SIRI-001617, SIRI-002157, siri-002135, SIRI-2302, siri-001903, siri-001904, siri-001911, SIRI-002041, SIRI-001858, SIRI -002150, SIRI-002156, siri-002166, siri-002168, siri-002169, siri-002171, siri-002201, SIRI-001854, SIRI-001785, SIRI-001786, SIRI-001954, SIRI-001850, SIRI-001862, SIRI-002159, SIRI-002304, SIRI-002315, and SIRI-002224

RECALLING FIRM/MANUFACTURER

Recalling Firm: Spacelabs Healthcare, LLC, Issaquah, WA, by letter on June 24, 2010.
Manufacturer: Blease Beech House Chiltern Court, Chesham, United Kingdom. Firm initiated recall is ongoing.
REASON

Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop.

VOLUME OF PRODUCT IN COMMERCE

80 units

DISTRIBUTION

IA, GA, LA, NC, TN, TX and Australia, Chile, China, India, Italy, Philippines, Mexico, Poland, Singapore, Thailand, Turkey, United Kingdom, and Venezuela

_____________________________________

PRODUCT

IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650. Recall # Z-2195-2010

CODE

Lots: T908069, T908104, T909110, T001036

FIRM/MANUFACTURER

Recalling Firm: Beckman Coulter Inc. Brea, CA, by letter beginning April 19, 2010.

Manufacturer: Beckman Coulter Inc., Carlsbad, CA. Firm initiated recall is ongoing.

REASON

Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.

VOLUME OF PRODUCT IN COMMERCE

1,309 units

DISTRIBUTION

Nationwide, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and United Kingdom

___________________________________

PRODUCT

1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST, REF 71163006, Qty: (6), Sterile R, CE 008, 2020/07, Usage: Bone fracture fixation. Recall # Z-2197-2010;

 

2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST, REF 71163008, Qty: (6), Sterile R, CE 008, 2020/07, Usage: Bone fracture fixation. Recall # Z-2198-2010;

 

3) PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, Qty: (6), Sterile FR, CE 0123, 2015/04, Usage: Bone fracture fixation. Recall # Z-2199-2010

CODE

1) Lot Number: 10DM13784;

2) Lot Number: 10DM08157;

3) Lot Number: 10DM08160

RECALLING FIRM/MANUFACTURER

Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letter, email and telephone on January 23, 2009. Firm initiated recall is ongoing.

REASON

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

VOLUME OF PRODUCT IN COMMERCE

43 units

DISTRIBUTION

KY, TX, DC, NC, CA, AZ, GA, OH, Australia, Malaysia, and Switzerland

___________________________________

PRODUCT

Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields. Recall # Z-2210-2010

CODE

Products are identified as Equipment numbers: 13046, 44791, 85095, 101036, 103238, 104497, 104950, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 505252, 506616, 520582, 520630, 520631, 520807, 521221, 522155, 530660, 533325, 533543, 534237, 534418, 536178, 538387, 538538, 538763, 538806, 540301, 540487, 540912, 541742, 542113, 542117, 543229, 544086, 544120, 544550, 545487, 547918, 547925, 548020, 549385, 550758, 550935, 551370, 551725, 554775, 554802, 555447, 555605, 558582, 34702, 105960, 25934, 38592, 41455, 45059, 52463, 62671, 82824, 83667, 85137, 85195, 86341, 86575, 86914, 86981, 87359, 87364, 100788, 101077, 101612, 101952, 102664, 103147, 103265, 103270, 103281, 103283, 103380, 103525, 103526, 103562, 103564, 103781, 103891, 104075, 104076, 104077, 104149, 104464, 104670, 105073, 105139, 105140, 105304, 105489, 105598, 105670, 105674, 105779, 105953, 500038, 504493, 504655, 504666, 504674, 504733, 504742, 504747, 504776, 504779, 505271, 505281, 505363, 505421, 505486, 505530, 505538, 505650, 505809, 505860, 505861, 505876, 505968, 506026, 506049, 506069, 506119, 506169, 506469, 506509, 506538, 506539, 506540, 506541, 506564, 506621, 506637, 506778, 519115, 519118, 519136, 519195, 519197, 519198, 519211, 519534, 519536, 519537, 519548, 519680, 519730, 519733, 519738, 519812, 519894, 519899, 519901, 520275, 520309, 520319, 520430, 520431, 520491, 520523, 520524, 520526, 520598, 520632, 520660, 520680, 520681, 520688, 520755, 520779, 520783, 520793, 520956, 520964, 520977, 521001, 521154, 521223, 521311, 521312, 521314, 521315, 521318, 521325, 521463, 521512, 521537, 521545, 521548, 521589, 521650, 521659, 521675, 521711, 521820, 521853, 521854, 521890, 521892, 522065, 522118, 522119, 522136, 522138, 522162, 522177, 522243, 522245, 522293, 522397, 522440, 522446, 522456, 522458, 530361, 530368, 530391, 530392, 530393, 530396, 530421, 530459, 530460, 530463, 530464, 530584, 530653, 530654, 530656, 530662, 530663, 530664, 530667, 530668, 530669, 530715, 530783, 531649, 531651, 531728, 531752, 531753, 531758, 531760, 531762, 531799, 531808, 531817, 531830, 531834, 531837, 531931, 531939, 531942, 531943, 531944, 531945, 531946, 531948, 531949, 531951, 531957, 531961, 532074, 532077, 532080, 532148, 532150, 532152, 532172, 532178, 532207, 532215, 532225, 532226, 532227, 532234, 532235, 532239, 532240, 532241, 532244, 532245, 532249, 532262, 532263, 532264, 532292, 532294, 532445, 532532, 532533, 532534, 532535, 532611, 532612, 532613, 532615, 532616, 532617, 532649, 532652, 532799, 532800, 532986, 532990, 533084, 533085, 533278, 533282, 533283, 533284, 533285, 533286, 533287, 533288, 533289, 533290, 533343, 533395, 533397, 533398, 533401, 533418, 533476, 533541, 533551, 533567, 533619, 533738, 533762, 533763, 533772, 533796, 533861, 533897, 533922, 533955, 533956, 533966, 533967, 534108, 534131, 534150, 534152, 534155, 534156, 534158, 534160, 534215, 534217, 534218, 534232, 534246, 534250, 534251, 534252, 534255, 534268, 534269, 534270, 534374, 534380, 534420, 534427, 534431, 534440, 534452, 534476, 534477, 534478, 534479, 534545, 534569, 534634, 534638, 534639, 534646, 534665, 534678, 534681, 534682, 534716, 534717, 534720, 534724, 534730, 534731, 534758, 534787, 534796, 534798, 534810, 534811, 534856, 534874, 534876, 534879, 534927, 534928, 534941, 535094, 535151, 535152, 535173, 535212, 535213, 535224, 535250, 535274, 535278, 535285, 535303, 535341, 535342, 535367, 535376, 535387, 535396, 535400, 535415, 535416, 535418, 535424, 535439, 535492, 535566, 535611, 535614, 535615, 535635, 535667, 535702, 535727, 535728, 535761, 535769, 535777, 535779, 535793, 535813, 535814, 535927, 535931, 535946, 535951, 535979, 535982, 536006, 536007, 536014, 536028, 536030, 536031, 536034, 536035, 536037, 536042, 536067, 536090, 536136, 536138, 536154, 536155, 536163, 536171, 536173, 536174, 536379, 536433, 536592, 536639, 536641, 536646, 536714, 536715, 536717, 536721, 536736, 536777, 536796, 536798, 536801, 536899, 536901, 536921, 536954, 536966, 536993, 537024, 537065, 537073, 537083, 537175, 537205, 537266, 537268, 537296, 537357, 537386, 537466, 537514, 537588, 537589, 537590, 537593, 537597, 537604, 537631, 537644, 537698, 537717, 537743, 537745, 537784, 537804, 537805, 537838, 537854, 537855, 537922, 537934, 537935, 537937, 537938, 537985, 538028, 538084, 538095, 538099, 538102, 538157, 538172, 538193, 538194, 538228, 538234, 538322, 538368, 538369, 538386, 538404, 538406, 538409, 538416, 538449, 538464, 538465, 538466, 538479, 538482, 538485, 538486, 538512, 538514, 538516, 538744, 538771, 538813, 538902, 538903, 538910, 538911, 539107, 539204, 539213, 539220, 539224, 539267, 539268, 539322, 539323, 539326, 539369, 539380, 539381, 539398, 539455, 539456, 539472, 539479, 539480, 539516, 539595, 539628, 539634, 539641, 539745, 540016, 540048, 540070, 540082, 540150, 540167, 540184, 540203, 540213, 540237, 540269, 540275, 540284, 540288, 540311, 540312, 540321, 540325, 540338, 540374, 540386, 540421, 540456, 540460, 540461, 540622, 540684, 540721, 540790, 540808, 540841, 540887, 540930, 540952, 540973, 541026, 541029, 541030, 541046, 541049, 541053, 541080, 541223, 541237, 541238, 541239, 541251, 541253, 541259, 541276, 541509, 541510, 541572, 541577, 541588, 541589, 541590, 541592, 541597, 541657, 541659, 541667, 541715, 541748, 541783, 541822, 541848, 541873, 541880, 542109, 542306, 542382, 542413, 542478, 542486, 542518, 542522, 542526, 542557, 542714, 542744, 542963, 543087, 543194, 543200, 543209, 543213, 543216, 543289, 543386, 543397, 543398, 543399, 543411, 543444, 543611, 543690, 543702, 543759, 543762, 543799, 543829, 543850, 543873, 543877, 543879, 543931, 543953, 543971, 543972, 543984, 543988, 543989, 543999, 544005, 544048, 544051, 544052, 544057, 544103, 544122, 544130, 544145, 544184, 544306, 544371, 544395, 544433, 544489, 544513, 544543, 544572, 544600, 544610, 544631, 544635, 544636, 544637, 544655, 544656, 544668, 544728, 544729, 544750, 544844, 544904, 544989, 544990, 544992, 545023, 545024, 545025, 545037, 545052, 545069, 545073, 545090, 545262, 545280, 545282, 545293, 545295, 545296, 545357, 545365, 545395, 545396, 545443, 545518, 545521, 545539, 545583, 545604, 545640, 545714, 545733, 545749, 545750, 545752, 545753, 545776, 545779, 545799, 545827, 545838, 545839, 545840, 545853, 545882, 545884, 545905, 545912, 545921, 545941, 545942, 545964, 545966, 545975, 545985, 545991, 545997, 546012, 546013, 546014, 546025, 546060, 546119, 546149, 546201, 546456, 546517, 546569, 546572, 546585, 546586, 546634, 546668, 546693, 546886, 546906, 546908, 546934, 547005, 547058, 547118, 547159, 547165, 547173, 547215, 547234, 547279, 547287, 547321, 547334, 547364, 547406, 547431, 547600, 547601, 547619, 547620, 547621, 547627, 547628, 547642, 547660, 547715, 547720, 547729, 547748, 547749, 547753, 547761, 547762, 547763, 547769, 547770, 547777, 547795, 547800, 547822, 547823, 547833, 547838, 547852, 547855, 547861, 547878, 547893, 547896, 547898, 547908, 547914, 547921, 547922, 547932, 547948, 547952, 547965, 547976, 547977, 548005, 548022, 548029, 548036, 548038, 548039, 548049, 548051, 548054, 548061, 548067, 548082, 548108, 548140, 548147, 548288, 548383, 548432, 548496, 548525, 548601, 548603, 548616, 548618, 548640, 548645, 548764, 548775, 548778, 548785, 548966, 549013, 549170, 549202, 549245, 549250, 549252, 549253, 549306, 549368, 549370, 549378, 549379, 549400, 549451, 549738, 549750, 549792, 549902, 549903, 549925, 549967, 550031, 550053, 550122, 550124, 550133, 550172, 550173, 550198, 550244, 550253, 550255, 550304, 550360, 550371, 550404, 550451, 550691, 550812, 551050, 551051, 551178, 551340, 551379, 551607, 551608, 551633, 551763, 551851, 551853, 551855, 552178, 552192, 552202, 552279, 552355, 552381, 552382, 552425, 552440, 552469, 552470, 552518, 552546, 552585, 552586, 552590, 552599, 552639, 552736, 552969, 553097, 553137, 553234, 553288, 553351, 553352, 553397, 553432, 553445, 553466, 553486, 553487, 553603, 553697, 553699, 553723, 553766, 553798, 553803, 553846, 553867, 553868, 553869, 553873, 553881, 553925, 553964, 553981, 553984, 554018, 554049, 554054, 554370, 554427, 554431, 554442, 554444, 554447, 554499, 554518, 554556, 554631, 554680, 554763, 554776, 554791, 554811, 555206, 555293, 555299, 555321, 555343, 555349, 555350, 555356, 555420, 555742, 555834, 555927, 556156, 556323, 556390, 556470, 556601, 556701, 556708, 556709, 556760, 556773, 556783, 556808, 556814, 556820, 556855, 556857, 557512, 558180, 558238, 558448, 536234 / 709270, 707730 / 532614, 85190, 86189, 505064, 505111, 519196, 520236, 520814, 520948, 521222, 521763, 533857, 536353, 536789, 538481, 539094, 539099, 543610, 547752, 553871, 553921, 554731, 555055, 556311, 558267, 560060, 41445816, 49599013, 505111, 203880, 215045, 215140, 505077, 505858, 519895, 522253, 534247, 534439, 534702, 534756, 535202, 535285, 538132, 540317, and 535326

RECALLING FIRM/MANUFACTURER

Recalling Firm: Philips Medical Systems North America Co. Phillips
Bothell, WA, by letter on July 2, 2008.

Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is complete.

REASON

Monitor ceiling carriage may separate from the monitor ceiling suspension.

VOLUME OF PRODUCT IN COMMERCE

1,111 units

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

Toshiba Aquilion ONE CT SystemTSX-301 A/2D. Recall # Z-2339-2010

CODE

Units: 2DA0872038, 2DA0862034, 2DA07X2008, 2DA0842023, 2DA07X2005, 2DA0882053, 2DA0882051, 2DA0862036, 2DA0882049, 2DA0882052, 2DA0842026, 2DA07Y2010, 2DA0882048, 2DA08X2061, 2DA0792004, and 2DA0792002

RECALLING FIRM/MANUFACTURER

Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated January 14, 2009.

Manufacturer: Toshiba Medical Systems, Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON

ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.

VOLUME OF PRODUCT IN COMMERCE

16 units

DISTRIBUTION

AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and PR

___________________________________

PRODUCT

Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers: PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52. Recall # Z-2399-2010

CODE

Lot numbers 926287, 937391, 931335, 933355, 935370, 937390, 940422, 916188, 917184, 919211, 920228, 922244, 925269, 916189, 917185, 919216, 920229, 923245, 925272, 952026, 002048, 005069, 916186, 918196, 919205, 920240, 924268, 926285, 916184, 918203, 919208, and 922239

RECALLING FIRM/MANUFACTURER

Peregrine Surgical LTD, New Britain, PA, by letter on July 19, 2010. Firm initiated recall is complete.
REASON

Product did not have proper 510(k) clearance.

VOLUME OF PRODUCT IN COMMERCE

132 boxes – 5 pieces per box (660 pieces total)

DISTRIBUTION

FL, MD, MO, NC, OH, PA, TX

___________________________________

PRODUCT

Sonopet Ultrasonic Surgical System, Model UST-2001. Recall # Z-2640-2010

CODE

Units: 06I0599, 08I0973, 07J0790, 04K0294, 07C0671, 09B1031, 04G0254, 04H0259, 06I0601, 08D0887, 06B0472, 05G0373, 07F0718, 07G0738, 05J0421, 08D0888, 04L0315, 05G0375, 04L0311, 06C0484, 04A0209, 08I0974, 04A0208, 03L0197, 07I0787, 09B1028, 07L0822, 06B0470, 04G0252, 05I0401, 09B1026, 06B0467, 06G556, 03I0166, 05E0378, 05E0351, 05J0422, 04D0237, 05L0448, 08C0872, 07E0703, 07L0825, 08L0998, 07K0811, 08G0937, 05J0423, 06B0468, 08D0885, 08D0891, 08G0935, 08G0936, 07E0700, 07E0701, 06H0576, 04D0230, 04D0231, 06I0603, 07B0655, 07B0653, 08G0932, 04F0242, 04I0262, 08D0889, 03I0168, 08B0855, 07K0807, 08A0847, 08B0858, 06F0543, 07F0721, 07F0719, 07F0720, 07F0732, 04K0293, 04I0279, 06G0569, 06K0618, 06I0586, 04K0292, 05A0341, 07K0808, 07H0766, 07H0767, 07E0714, 04H0261, 05L0444, 05L0446, 07K0810, 07K0812, 07K0813, 07L0830, 08D0893, 07E0705, 06H0574, 06H0577, 06H0578, 06I0588, 08I0985, 08I0972, 09B1035, 08F0914, 07F0731, 04G0253, 07F0722, 07K0805, 04K0295, 07C0672, 07K0806, 08B0857, 07B0652, 07G0739, 05E0379, 07I0785, 07I0786, 06G0567, 04I0282, 08E0907, 07I0788, 07I0789, 04I0271, 06C0488, 06C0487, 04B0194, 08D0886, 06B0473, 06C0486, 09B1027, 04H0260, 06A0456, 06E0532, 07C0670, 06I0602, 06C0489, 06E0530, 03L0196, 04J0283, 06G0568, 03I0170, 06B0475, 03I0171, 08G0934, 07F0717, 08F0925, 08A0843, 03H0165, 06G557, 06G555, 08L0999, 06A0459, 06A0460, 06A0461, 09A1008, 09A1009, 09A1010, 09A1016, 07L0827, 07L0828, 07L0829, 08C0871, 08C0873, 08C0874, 08C0875, 09B1034, 08D0890, 09C1051, 06D0511, 09E1069, 09E1070, 09E1071, 09E1085, 09E1086, 08E0895, 08E0896, 08F0926, 08F0927, 08F0928, 08F0929, 08F0930, 08G0938, 06H0573, 07K0623, 07G0735, 07G0736, 06H0575, 06I0589, 06K0621, 03G0162, 04D0236, 05L0447, 06D0510, 07H0764, 07H0765, 06G558, 06D0512, 07L0824, 09A1017, 08D0877, 06H0572, 06H0571, 06C0490, 06H0579, 08B0859, 08B0854, 08I0970, 06B0469, 06F0545, 09B1032, 09B1033, 08D0892, 09C1049, 09C1050, 07E0704, 08E0905, 08E0906, 06C0491, 07E0699, 06I0590, 05L0445, 07H0763, 06C0492, 07K0622, 07E0702, 06G0554, 07G0740, 08F0915, 07J0791, 07C0669, 06E0534, 07G0741, 06I0587, 03L0195, 06I0600, 05F0381, 07B0656, 08B0860, 04L0313, 07L0823, 08A0842, 08G0933, 05G0374, 07G0742, 06K0620, 07G0747, 07D0688, 04I0272, 05G0390, 05I0400, 05H0397, 06C0485, 08B0856, 07F0716, 07D0684, 06F0544, 08F0916, 07K0809, 03G0163, 06B0474, 05G0389, 07A0643, 08F0912, 05F0380, 02#0065, 04G0251, 03I0172, 04I0273, 04F0244, 07L0832, 08I0984, 09B1025, 06B0471, 08A0848, 06E0531, 06E0533, 08E0908, 08G0939, 04F0245, 06J0604, 07G0743, 07G0745, 05G0396, 05G0395, 05H0398, 06H0570, 07D0685, 02%0075, 02%0076, 04L0312, 07D0687, 05G0392, 03D0134, 02I0109, 02I0110, 03I0169, 07G0748, 03E0161, 07B0657, 06A0457, 04I0280, 04I0281, 04K0291, 07G0746, 08G0931, 07B0654, 07F0730, 06K0619, 05A0342, 05G0391, 03I0167, 04C0223, 06F0542, 03H0164, 08I0971, 08F0913, 06J0617, 03G0148, 03G0149, 03G0150, 04C0222, 04K0310, 04A0205, 04K0309, 03I0173, 02L0119, 03A0124, 02#0057, 02G0092, 01(0010, 01J0024, 02!0041, 01+0028, 01,0034, 01,0032, 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RECALLING FIRM/MANUFACTURER

Recalling Firm: Stryker Instruments, Division of Stryker Corp., Kalamazoo, MI, by letters dated July 15, 2010.

Manufacturer: Stryker Medtech, Tokyo, Japan. Firm initiated recall is ongoing.
REASON

Stryker determined that the Sonopet consode did not meet the IEC-60601-1 standard. Stryker decided to recall the Sonopet consode.

VOLUME OF PRODUCT IN COMMERCE

1,146 units

DISTRIBUTION

Nationwide and Internationally

 

END OF ENFORCEMENT REPORT FOR OCTOBER 27, 2010

 

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