Safety

Enforcement Report for January 25, 2012

January 25, 2012
12-04
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

PRODUCT
Instantwhip B/C Topping, 64 Fl oz, Laminated carton. Recall # F-0594-2012
CODE
Julian date codes include the following codes: 060, 080, 124, 143, 145, 167, 179, 188, 193, 244, 256, 300, and 313 Expiration Date Codes include the following codes: Exp date: Dec 16 11, Dec 21 11, Dec 28 11, Dec 30 11, Jan 7 12, Jan 12 12
RECALLING FIRM/MANUFACTURER
Ohio Processors Inc., London, OH, by press release and telephone on December 15, 2011. Firm initiated recall is ongoing.
REASON
The product contains an undeclared milk ingredient (sodium caseinate).
VOLUME OF PRODUCT IN COMMERCE
1,326 cs/9/64 fl oz cartons
DISTRIBUTION
IN, MD, MI, NY, OH & PA

PRODUCT
  1. Fresh Spinach sold under the following brand names: 1) Better Brand Fresh Spinach, 10 oz; 2) Krisp Pak Brand Fresh Spinach, 10 oz. Grown in USA. Recall # F-0602-2012;
  2. Avon Heights - Select Savoy, 2.5 lb. Grown in USA. Recall # F-0603-2012
CODE
Same for both brands: Best if used by: DEC 16.DP34.T691
RECALLING FIRM/MANUFACTURER
Recalling Firm: Avon Heights Mushrooms, Inc., Avondale, PA, by facsimile and telephone December 23, 2011.
Manufacturer: Tiro Tres Farms, Eagle Pass, TX. New York initiated recall is ongoing.
REASON
NYSDAM testing revealed the presence of E. coli 0157:H7 in one 10 oz bag (Better Brand).
VOLUME OF PRODUCT IN COMMERCE
16,000 units
DISTRIBUTION
MD, PA, NJ, and NY

PRODUCT
  1. Fromagerie Marie Kade Akawi Cheese Establishment number 1874 300-400 g; UPC 7 78546 07000 8. Recall # F-0606-2012;
  2. Fromagerie Marie Kade Baladi Cheese Establishment number 1874 300-400 g; UPC 7 78546 02000 3. Recall # F-0607-2012;
  3. Fromagerie Marie Kade Shinglish Cheese Establishment number 1874 approx. 200 g; UPC 7 78546 10000 2. Recall # F-0608-2012;
  4. Fromagerie Marie Kade Tresse Cheese Establishment number 1874 300-400 g. UPC 7 78546 01000 4. Recall # F-0609-2012;
  5. Fromagerie Marie Kade Vachekaval Cheese Establishment number 1874 300-400 g; UPC 7 78546 11000 1. Recall # F-0610-2012;
  6. Fromagerie Marie Kade Halloom Cheese Establishment number 1874 300-400 g;
    UPC 7 78546 03000 2. Recall # F-0611-2012;
  7. Fromagerie Marie Kade Moujadale Cheese Establishment number 1874 300-400 g Packaged in flexible plastic; UPC 7 78546 04000 1. Recall # F-0612-2012
CODE
  1. Best before and up to 08 MAR 2012;
  2. Best Before and up to 08 FEB 2012;
  3. Best Before and up to 07 NOV 2012;
  4. Best Before and up to 10 NOV 2012;
  5. Best Before and up to 10 MAR 2012;
  6. Best Before and up to 01 May 2012;
  7. Best Before and up to 04 May 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cedar Markets Inc., Norwood, MA, by telephone and email beginning December 27, 2011.
Manufacturer: Fromagerie Marie Kade Inc., Boisbriand, Canada. Firm initiated recall is complete.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
40 cases
DISTRIBUTION
MA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

PRODUCT
Swanson Ultra Softgels, Q Gel Mega 100, Dietary Supplement, 60 Softgels, 100 mg., Serving Size 1 softgel : Vitamin E (as d-alpha tocopherol) 150 IU, Q-Gel Coenzyme Q-10 100 mg, Other Ingredients: Gelatin, sorbitol, glycerin, purified water, proprietary Bio-Solv base (polysorbate 80, sunflower lecithin, medium,-chain triglycerides, annatto seed extract, soybean oil. Recall # F-0595-2012
CODE
Lot 189588
RECALLING FIRM/MANUFACTURER
Recalling Firm: Swanson Health Products, Inc., Fargo, ND, byletter on January 9, 2012.
Manufacturer: Tishcon Corp., Westbury, NY. Firm initiated recall is ongoing.
REASON
The product contains undeclared soy lecithin instead of the sunflower lecithin reflected in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
652 bottles
DISTRIBUTION
Nationwide except VT and WY. OUS: Canada, Hong Kong, Israel and Taiwan

PRODUCT
Takovo Ratluk Turkish Delight - Rose Jelly Candy (Laokoum); a powdered rose flavored jelly candy packaged in Net Wt. 15.88 oz. (450 g) cardboard boxes, 12 boxes per case; UPC 601900 605320. Recall # F-0596-2012
CODE
All batches imported between February 2011 and December 2011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: A.B. Company Inc., Lincolnwood, IL, by letters dated December 12, 2011.
Manufacturer: Swisslion Group Doo, Novi Sad, Serbia. New York initiated recall is ongoing.
REASON
The rose flavored jelly candy contains the color E124 which is also known as Ponceau 4R, which is a non-permitted color additive in any food in the U.S.
VOLUME OF PRODUCT IN COMMERCE
401 cases
DISTRIBUTION
Nationwide and Canada

PRODUCT
Pimiento Chorizero. Food additive/flavoring for sausage. 55 lb brown paper bag. The bag may not bear a label. For bags that do bear a label, the labeling reads in part:"cemix COLORANTE PARA CONCERTO***". Firm's identifying code, Mojave Foods Item # 510392, Shipping dates 01/01/2011 to 01/26/2011. Recall # F-0597-2012
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Mojave Foods Corp., Los Angeles, CA, by letter and verbally on February 10, 2011. FDA initiated recall is complete.
REASON
FDA's analysis revealed the presence of unapproved colors - Ponceau 4R and Carmoisine and uncertified color additives including Sunset Yellow FCF, which is certifiable as FD&C Yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
8.085 lbs
DISTRIBUTION
AZ, TX

PRODUCT
14.5 oz can labeled in part: "Winn Dixie Brand Italian Green Beans***UPC 2114021236***". Recall # F-0598-2012
CODE
Lot IPBN212BX Sell by SEP 2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Winn Dixie Stores, Inc., Jacksonville, FL, by e-mail beginning December 28, 2011.
Manufacturer: McCall Farms Inc., Effingham, SC. Firm initiated recall is ongoing.
REASON
Recall due to a potential for in-shell peanuts mixed with the green beans. Individuals with an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction.
VOLUME OF PRODUCT IN COMMERCE
4,419 cases
DISTRIBUTION
FL, GA, MS, AL, and LA

PRODUCT
  1. Fruta Cristalizada (Cubos) Net Wt: 8.8 Oz. (250 gr.) Product of Portugal Packaged in non-flexible plastic container, UPC Code: 5601528837137. Recall # F-0599-2012;
  2. Confeitaria da Ajuda Chrystallized Assorted Fruit Cubes, Net Weight: 350 oz (5 kg.). Packaged in a cardboard box. Recall # F-0600-2012
CODE
  1. None;
  2. Lot # SS0009, Best before March 2012 end:
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lusitano Food & Home Products LLC, New Bedford,MA, by letter and visit beginning January 11, 2012.
Manufacturer: Confeitaria da Ajuda, Lisboa, Portugal. New York Initiated recall is ongoing.
REASON
NYSDAM's analysis revealed the presence of unapproved colors - PONCEAU 4R and Patent Blue V. The product also contains undeclared FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
6 (5 kg.) cases (2 sold in bulk, remainder as 250 g containers)
DISTRIBUTION
MA, NY

PRODUCT
On the Border Mexican Grill & Cantina Frozen Pina Colada Drink Mix 64 fl oz (1.89L) MADE WITH 10% FRUIT JUICE!** ALL NATURAL FLAVORS. Product can be shipped one of the following ways: 1) Display pallet (Assorted) - 42 each, 2) Display Pallet (Assorted - Military) - 84 each, 3) Pallet (Pina Colada in Cases) - 294 each (49 cases of 6 per case), or 4) Online Orders - Sold as Individual Buckets (Each) UPC Number 7-81138-41706-8. Recall # F-0601-2012
CODE
All Lot Numbers. Lot Code Dates: BEST BY 02/24/12 - BEST BY 06/30/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Truco Enterprises, Inc., Dallas,TX, by letter dated December 28, 2011.
Manufacturers: Jus Made, Inc., Dallas,TX;
National Food & Beverage, Inc., Dallas,TX. Firm initiated recall is ongoing.
REASON
Recent discovery of a supplier documentation error revealed that On The Border PINA COLADA 64 oz DRINK MIX BUCKETS may contain an Undeclared Allergen - Coconut (Treenut).
VOLUME OF PRODUCT IN COMMERCE
91,666 units
DISTRIBUTION
Nationwide

PRODUCT
  1. Breaded Herring Fillets (Opiekane filety sledziowe panierowane); packed in glass jars, Net wt. 14 oz. (400 g) drained 7 oz. (200 g); Product of Poland; UPC 6 17115 00501 3. Recall # F-0604-2012;
  2. Breaded Mackerel Fillets (Opiekane filety z makreli panierowane); packed in glass jars, Net wt. 1 lb. 7 oz. (650 g) drained 12 oz. (350 g); Product of Poland; UPC 6 17115 00502 0. Recall # F-0605-2012
CODE
  1. Best Before 02/24/12 343H, 03/20/12 373H, 03/30/12 394H and 03/30/12 395J;
  2. Best Before 03/13/12 352G, 03/20/12 372G, 03/20/12 373H and 03/30/12 394F
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lowell International & Lowell Foods, Franklin Park, IL, by letters dated December 27, 2011.
Manufacturer: Contimax, S.A., Bochnia, Poland. FDA initiated recall is ongoing.
REASON
The breaded fish fillets contain wheat flour which is not declared in the ingredients statement on the labels, nor is there a wheat allergen statement present on the labels.
VOLUME OF PRODUCT IN COMMERCE
4,200 jars
DISTRIBUTION
Nationwide
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS

PRODUCT
 
CODE
 
RECALLING FIRM/MANUFACTURER
 
REASON FOR RECALL
 
FIELD CORRECTIONS: DRUGS - CLASS II

PRODUCT
Fluoxetine Capsules USP 10 mg, Rx only, 1000 Capsules, NDC 0781-2823-10. Recall # D-1177-2012
CODE
Lot BR7539
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on January 5, 2012.
Manufacturer: Sandoz, Inc., Broomfield, CO. Firm initiated recall is ongoing.
REASON
Microbial contamination of non-sterile product (gelatin capsules contamination).
VOLUME OF PRODUCT IN COMMERCE
252 x 1000 ct bottles
DISTRIBUTION
Nationwide

PRODUCT
0.9% Sodium Chloride Injection, USP, 500mL, NDC 0409-7983-03. Recall # D-1178-2012
CODE
Lot # 06-830-FW
RECALLING FIRM/MANUFACTURE
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on December 9, 2011.
Manufacturer: Hospira, Inc., Rocky Mount. NC. Firm initiated recall is ongoing.
REASON
Failed PH Specifications: The product is being recalled because of a confirmed out of specification result for pH.
VOLUME OF PRODUCT IN COMMERCE
479,352 bags
DISTRIBUTION
Nationwide, U.S. Virgin Islands, Puerto Rico and Trinidad and Tobago

PRODUCT
Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/mL,
  1. 1mL Vials (NDC 0703-6801-01);
  2. box of 25 single dose vials (NDC 0703-6801-04) and
  3. 1mL Prefilled Syringes (NDC 0703-6811-21), Rx only, For IM Use Only. Recall # D-1180-2012
CODE
  1. Lot numbers 31310301B, exp 12/2011; 31310788B, exp 1/2012; 31311008B, exp 4/2012;
  2. lot numbers - 31310787B, exp 1/2012; 31311357B, exp 4/2012; and
  3. lot numbers 31311217B, exp 2/2012; 31311219B, exp 2/2012; 31312156B, exp 4/2012; 31312300B, 4/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 1, 2011.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is
ongoing.
REASON
Presence of Particulate Matter; presence of silicone particles.
VOLUME OF PRODUCT IN COMMERCE
229,470 units
DISTRIBUTION
Nationwide and PR
 
FIELD CORRECTIONS: DRUGS - CLASS III

PRODUCT
Fluocinonide, Ointment USP, 0.05%, NDC 51672-1264-2. Packaged in phenolic lacquer aluminum tubes with two sizes: 30g UPC: 351672126421; 60g UPC: 351672126438. Recall # D-1176-2012
CODE
Lot # J9066, 10/12; J9069, 10/12; J9070, 10/12; J9071, 10/12; K9001, 11/12; K9002, 11/12; K9003, 11/12; K9004, 11/12; K9005, 11/12; K9006, 11/12; K9007, 11/12; K9113, 11/12; K9114, 11/12; K9115, 11/12; K9116, 11/12; K9117, 11/12; K9118, 11/12; K9119, 11/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals USA, Inc., Hawthorne, NY, by letter on September 28, 2011.
Manufacturer: Taro Pharmaceuticals, Inc., Brampton, Canada. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out-of specification result for a known degradant Fluocinolone Acetonide. Taro Pharmaceuticals, Inc is recalling specific lots of Fluocinonide Ointment USP, 0.05% based on an investigation regarding out-of-specification (OOS) results for a known degradant observed in Fluocinonide Ointment USP, 0.05%, long-term stability lots # J9066 at 22-month interval, and # K9003 and # K9115 at 21-month intervals.
VOLUME OF PRODUCT IN COMMERCE
111,360 units
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

PRODUCT
  1. Cryoprecipitated AHF, Pooled. Recall # B-0378-12;
  2. Plasma Frozen within 24 hours (FP24). Recall # B-0379-12;
  3. Red Blood Cells Leukocytes Reduced. Recall # B-0380-12
CODE
  1. Unit: 6571965;
  2. Units: 6568228; 6548844;
  3. Units: 6568228; 6571965; 6548844
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on August 29, 2011 and September 7, 2011. Firm initiated recall is complete.
REASON
Blood Products, in which NAT re-entry testing was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL, TX

PRODUCT
Fresh Frozen Plasma. Recall # B-0381-12
CODE
Unit: W115111254817P
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on September 21, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0382-12
CODE
Unit: W1151112548747
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on October 5, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0383-12
CODE
Unit: W038111209567
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter on September 22, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with Polycythemia Vera, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

PRODUCT
Red Blood Cells. Recall # B-0389-12
CODE
Unit: W038511383332
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on November 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

PRODUCT
Red Blood Cells (Apheresis). Recall # B-0391-12
CODE
Units: W038111270732; W038111270764
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by telephone on September 30, 2011 and letter on October 3, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled 'leukoreduced', but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

PRODUCT
Recovered Plasma. Recall # B-0392-12
CODE
Unit: W333610045499
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport,IA, by shared database on October 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0393-12
CODE
Unit: W158011200769
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by electronic mail on October 21, 2011 and letter on October 27, 2011. Firm initiated recall is complete.
REASON
Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT

PRODUCT
  1. Recovered Plasma. Recall # B-0427-12;
  2. Red Blood Cells Leukocytes Reduced. Recall # B-0428-12;
  3. Cryoprecipitated AHF. Recall # B-0429-12;
  4. Fresh Frozen Plasma. Recall # B-0430-12;
  5. Plasma Frozen Cryoprecipitated Reduced. Recall # B-0431-12
CODE
  1. Units: 1811150, 1808269, 1711496, 1708784;
  2. Units: 1811150, 1808269, 1711496, 1710737, 1708784, 1617461;
  3. Unit: 1617461;
  4. Unit: 1710737;
  5. Unit: 1617461
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on April 25, 2008 and by letter dated May 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
WA, ID, FL, Austria

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0433-12
CODE
Units: 6725862, 6527837
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on May 8, 2008 and June 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received human growth hormone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK, NJ

PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0434-12
CODE
Unit: W068508345996
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on May 21, 2008. Firm initiated recall is complete.
REASON
Blood product, which had a low hemoglobin level, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Red Blood Cells. Recall # B-0439-12
CODE
Unit: 2700787
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated May 6, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Tazorac, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

PRODUCT
Recovered Plasma. Recall # B-0441-12
CODE
Unit: W141607534804
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by electronic notification on May 13, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

PRODUCT
Recovered Plasma. Recall # B-0442-12
CODE
Unit: W141607116996
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle,WA, by electronic notification on May 13, 2008.
Manufacturer: Puget Sound Blood Center and Program, Bellingham,WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0445-12
CODE
Units: W1416081301061, W1416081301062
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated March 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0448-12
CODE
Units: 20FK26699, 20FK26976
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise,ID, by telephone, facsimile, or electronic notification on May 8, 2008.
Manufacturer: American National Red Cross, Kalispell,MT. 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
MT, CA

PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0455-12
CODE
Unit: W141608390988
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on February 18, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Red Blood Cells. Recall # B-0456-12
CODE
Unit: W141608390560
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on February 11, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Red Blood Cells. Recalling Firm: B-0457-12
CODE
Unit: W141607418998
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on January 16, 2008.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Fresh Frozen Plasma. Recall # B-0458-12
CODE
Unit: W141607492522
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle,WA, by facsimile on February 15, 2008.
Manufacturer: Puget Sound Blood Center and Program, Olympia,WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

PRODUCT
Red Blood Cells. Recall # B-0463-12
CODE
Unit: W036811072727
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill,FL, by letter on October 17, 2011. 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
Switzerland, FL

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0489-12
CODE
Units: W038111042394, W038110357267
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on October 3, 2011 and letter on October 4, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who emigrated from an area considered endemic for malaria and received a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0292-12
CODE
Unit: 27KW39921
RECALLING FIRM/MANUFACTURER
American Red Cross Greater Alleghenies Region, Johnstown, PA, by telephone and letter on September 15, 2011. 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
WV

PRODUCT
Red Blood Cells. Recall # B-0390-12
CODE
Unit: W051511055528
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul,MN, by letter on November 4, 2011.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with Hemachromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0394-12
CODE
Units: W333611089675; W333611088459
RECALLING FIRM/MANUFACTURER
Mississippi Valley Region Building Center, Davenport, IA, by telephone and facsimile on October 25, 2011 and a second notification was sent on October 28, 2011. Firm initiated recall is complete.
REASON
Blood products, manufactured without the entire quantity of additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL, IA

PRODUCT
Recovered Plasma. Recall # B-0432-12
CODE
Units: 6725862, 6527837
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on May 8, 2008 and June 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received human growth hormone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK, NJ

PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0435-12
CODE
Unit: W141608044018
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on May 2, 2008.
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA. 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
WA

PRODUCT
Source Plasma. Recall # B-0436-12
CODE
Unit: 07GMTE2718
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Great Falls, MT, by facsimile on April 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

PRODUCT
Platelets. Recall # B-0438-12
CODE
Unit: W141608132802
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on April 21, 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
WA

PRODUCT
Red Blood Cells. Recall # B-0440-12
CODE
Unit: W141608393162
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by facsimile on May 7, 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
WA

PRODUCT
  1. Recovered Plasma. Recall # B-0447-12;
  2. Plasma Frozen. Recall # B-0449-12
CODE
  1. Unit: 20FK26699;
  2. Unit: 20FK26976
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise,ID, by telephone, facsimile, or electronic notification on May 8, 2008 and follow-up notification on August 17, 2008.
Manufacturer: American National Red Cross, Kalispell,MT. 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
MT, CA

PRODUCT
Recovered Plasma. Recall # B-0462-12
CODE
Unit: W036811072727
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida Inc., Lauderhill,FL, by letter on October 17, 2011. 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
Switzerland, FL
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I

PRODUCT
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Recall # Z-0296-2012
CODE
Serial Numbers: GV111030238, GV111040533, GV111040627, GV111040632, GV111040640, GV111040651, GV111040652, GV111040653, TV011031510, TV011040511, TV011040516, TV011040518, TV011040524, TV011040529, TV011040530, TV011040601, TV011040602, TV011040609, TV011040615, TV109081805, TV109081806, TV109081807, TV111021835, TV111022551, TV0111022832, TV111030422, TV111030441, TV111030445, TV111030453, TV111030774, TV111030790, TV111030853, TV111030932, TV111030947, TV111030976, TV111030978, TV111031001, TV111031011, TV111031037, TV111031045, TV111031057, TV111031064, TV111031067, TV111031113, TV111031403, TV111031413, TV111031420, TV111031462, TV111031554, TV111032252, TV111032254, TV111032306, TV111032316, TV111032562, TV111032809, TV111032811, TV111032812, TV111032822, TV111032827, TV111032829, TV111032830, TV111032832, TV111032833, TV111032901, TV111032905, TV111032906, TV111032909, TV111032912, TV111032913, TV111032914, TV111032920, TV111032923, TV111032924, TV111032925, TV111032926, TV111032929, TV111032934, TV111032935, TV111032938, TV111032939, TV111032940, TV111033001, TV111033004, TV111033005, TV111033006, TV111033009, TV111033010, TV111033016, TV111033018, TV111033019, TV111040110, TV111040113, TV111040117, TV111040404, TV111040405, TV111040411, TV111040415, TV111040416, TV111040418, TV111040419, TV111040420, TV111040423, TV111040424, TV111040428, TV111040432, TV111040438, TV111040703, TV111040729, TV111040735, TV111040803, TV111040808, TV111040830, TV111041118, TV111041304, TV111041306, TV111041435, TV111041436, TV211032405, TV211032409, TV211032412, TV211032413, TV211032414, TV211032415, TV211032419, TV211032420, TV211032430, TV211032431
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by telephone on October 11, 2011. Firm initiated recall is ongoing.
REASON
Units being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II

PRODUCT
  1. LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00065 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0206-2012;
  2. LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Model FG-00084 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. The ACT III will provide more sensitive data for initial or early detection of arrhythmia in patients that have minimal or atypical symptoms. Recall # Z-0207-2012;
  3. ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; there are two models used with either the ACT 1 sensor or the ACT III sensor: a) Model Ozone-HTC b) Model BlackJack2 SGH-i617 LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service. Recall # Z-0208-2012
CODE
  1. All serial numbers with firmware REV 01.G;
  2. All serial numbers with firmware REV 10.4;
  3. All serial numbers with software version 5.5.9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifewatch Services Inc., Rosemont, IL, by letter dated September 27, 2011.
Manufacturer: Card Guard Scientific Survival LTD, Rehovot, Israel. Firm initiated recall is ongoing.
REASON
LifeWatch received complaints of minor shocks and burns during use of the LifeStar ACT systems with shorts in the leads.
VOLUME OF PRODUCT IN COMMERCE
562 sensors, 532 phones
DISTRIBUTION
Nationwide

PRODUCT
SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material. Recall # Z-0209-2012
CODE
SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter on July 13, 2011. Firm initiated recall is ongoing.
REASON
SoftPath architecture does not correctly handle AP macros and data fields inside report sections that are stored in the database. Improper information can be displayed in all places where the diagnosis from the database is read and displayed.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide, PR, and Canada

PRODUCT
SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and report laboratory data. Recall # Z-0277-2012
CODE
SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter on May 3, 2011. Firm initiated recall is ongoing.
REASON
A client reported the PT and INR results did not get flagged. The PROT should have been flagged as HIGH and the INR should have been flagged as PANIC. Neither test was flagged.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide and Canada

PRODUCT
Elekta Synergy XVI X-ray Volume Imaging System to be used as part of radiation therapy treatment process. Recall # Z-0342-20212
CODE
Units: G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross,GA, by letter dated October 20, 2011.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps). Crawley, West Sussex, UK. Firm initiated recall is ongoing.
REASON
A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide, DC, PR

PRODUCT
  1. Maquet Servo-i ventilator system Device Part number 64 87 800, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0352-2012;
  2. Maquet Servo-S ventilator system Device Part number 66 40 440, 510 k 041223; Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall #Z-0353-2012;
  3. Maquet PC Board PC1772 Spare Part Device Part number 64 67 620, 510 k 041223 Device Listing No. B052264. Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. Recall # Z-0354-2012
CODE
  1. Lot number S/N 48396-49564;
  2. Lot number S/N 16783-17318;
  3. No lot S/N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc., Wayne, NJ, by letter dated September 19, 2011.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24).
VOLUME OF PRODUCT IN COMMERCE
202 units
DISTRIBUTION
Nationwide

PRODUCT
RayStation Version 2.0.0.15 Consult instruction for use. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. Recall # Z-0359-2012
CODE
Software version and build number is 2.0.0.15
RECALLING FIRM/MANUFACTURER
RaySearch Laboratories AB, Stockholm, Sweden, by letter dated October 19, 2011. Firm initiated recall is ongoing.
REASON
The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.
VOLUME OF PRODUCT IN COMMERCE
19 Units (14 units Nationwide; 5 units Internationally)
DISTRIBUTION
Nationwide and Netherlands

PRODUCT
  1. ActiveCare +SFT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-01 and A502B-0002-01. Recall # Z-0386-2012;
  2. ActiveCare DVT Medical Compression Systems. Intended for use in: Preventing deep Vein Thrombosis; Enhancing blood circulation; Diminishing post-operative pain and swelling; Reducing wound healing time; treatment and assistance in healing of stasis dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-02 and H502B-0001-07. Recall # Z-0387-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genesis Manufacturing Inc., Fortville, IN, by letters dated September 15, 2011.
Manufacturer: Medical Compression Systems, OR Aqiva, Israel. Firm initiated recall is ongoing.
REASON
MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT device may work improperly if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual, the ActiveCare DVT devices must only be used with the MCS AC/DC Adaptor. The ActiveCare DVT device could result in the device overheating and render the device unusable.
VOLUME OF PRODUCT IN COMMERCE
2768 (ActiveCare DVT 2217 units and ActiveCare+SFT 551 units)
DISTRIBUTION
Nationwide

PRODUCT
Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent. HSI number 123-7426. Recall # Z-0390-2012
CODE
Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012)
RECALLING FIRM/MANUFACTURER
Henry Schein, Inc., Melville, NY, by letter dated November 10, 2011. Firm initiated recall is ongoing.
REASON
The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
VOLUME OF PRODUCT IN COMMERCE
18,855 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
Dental cement under the brand name a) Cement-It, Part No. N33, N33A; and b) Natural Elegance (private label of Cement-It) Part No. SHN9004110. The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It), are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives. Recall # Z-0454-2012
CODE
  1. Syringe Lot No. 183058; Package Lot No. 186272, 186665, 186676;
  2. Syringe Lot No. 183058; Package Lot 182990, 186133, 188996
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation and Pentron Clinical, Orange, CA, by letters dated April 4, 2011 and April 20, 2011. Firm initiated recall is ongoing.
REASON
Product sets faster than specified in the "Directions for Use" and in release specifications.
VOLUME OF PRODUCT IN COMMERCE
157 units
DISTRIBUTION
Nationwide, Canada, Egypt, Israel, Netherlands, Sweden and UK

PRODUCT
  1. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112 cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8369. Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0469-2012;
  2. Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension Set, 61" (155 cm), Vol. 8.5 mL, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8371 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0470-2012;
  3. Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8376 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0471-2012;
  4. Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8533 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0472-2012;
  5. Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8581 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0473-2012;
  6. Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 1C8621 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0474-2012;
  7. Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6605 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall # Z-0475-2012;
  8. Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6921 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0476-2012;
  9. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension Set, Vol. 6.2 mL, Length 41" (104 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6931 Intended use: for the administration of sterile I.V. fluids to the patient. Recall # Z-0477-2012;
  10. Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 2C6951 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0478-2012;
  11. Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Extension Set, 43" (109 cm), Vol. 6.5 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0039 Intended use: for the administration of drug and solutions to patient's vascular system through a vascular access device. Recall #Z-0479-2012;
  12. Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol. 1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the patient; product code 3C0142 Intended use: for the administration of sterile I.V. fluids to the patient. Recall Z-0480-2012;
  13. Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6832 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0481-2012;
  14. Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95" (2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets; product code 4C6838 Intended use: for the removal of micro aggregates from whole blood or red blood cells and transfusion of platelets. Recall # Z-0482-2012
CODE
  1. Lot number GR296251;
  2. Lot number GR295493;
  3. Lot number GR294363;
  4. Lot number GR295337;
  5. Lot number GR296137;
  6. Lot numbers GR295352, GR296095 and GR296335;
  7. Lot number GR295725;
  8. Lot number GR295634;
  9. Lot numbers GR295956, GR296095, GR296848 and GR297416;
  10. Lot number GR296053;
  11. Lot number GR295642;
  12. Lot numbers: GR295287 and GR29641;
  13. Lot number: GR296319;
  14. Lot number: GR29538
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by letter dated December 6, 2011.
Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection.
VOLUME OF PRODUCT IN COMMERCE
48,489 units
DISTRIBUTION
Nationwide and New Zealand

PRODUCT
Portal Vision, R-Arm with 4D Integrated Treatment Console; Model H80, H81. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment. Recall # Z-0516-2012
CODE
Serial numbers: H800017 H800447 H800692 H801949 H803815 H803912 H803999 H804090 H804178 H804271 H804348 H804439 H804523 H800031 H800453 H800693 H801951 H803816 H803913 H804000 H804091 H804179 H804272 H804349 H804442 H804524 H800037 H800457 H800696 H801952 H803818 H803914 H804002 H804092 H804188 H804273 H804350 H804443 H804525 H800054 H800467 H800703 H801955 H803822 H803919 H804003 H804094 H804191 H804274 H804351 H804444 H804526 H800060 H800469 H800708 H801969 H803825 H803922 H804004 H804095 H804192 H804275 H804352 H804446 H804527 H800064 H800470 H800710 H801971 H803826 H803923 H804006 H804097 H804193 H804276 H804354 H804447 H804528 H800065 H800474 H800713 H801976 H803827 H803925 H804007 H804099 H804194 H804278 H804355 H804448 H804529 H800073 H800489 H800714 H801986 H803828 H803928 H804008 H804100 H804198 H804279 H804356 H804449 H804530 H800077 H800490 H800800 H801991 H803829 H803930 H804009 H804101 H804199 H804280 H804358 H804450 H804531 H800079 H800498 H800801 H801993 H803830 H803932 H804010 H804105 H804200 H804281 H804362 H804451 H804534 H800085 H800500 H800802 H801994 H803834 H803933 H804012 H804106 H804202 H804282 H804364 H804452 H804535 H800091 H800501 H800812 H801996 H803835 H803934 H804013 H804108 H804203 H804284 H804365 H804454 H804536 H800095 H800503 H800819 H801997 H803836 H803935 H804014 H804111 H804205 H804287 H804367 H804455 H804537 H800096 H800505 H800827 H802000 H803838 H803937 H804015 H804112 H804207 H804288 H804368 H804456 H804540 H800100 H800521 H800844 H802011 H803840 H803938 H804017 H804113 H804208 H804289 H804370 H804458 H804541 H800103 H800522 H800859 H802017 H803841 H803940 H804018 H804114 H804209 H804291 H804371 H804459 H804542 H800109 H800527 H800860 H802019 H803845 H803941 H804021 H804115 H804212 H804294 H804372 H804461 H804543 H800133 H800528 H800868 H802022 H803847 H803942 H804023 H804116 H804213 H804295 H804373 H804464 H804544 H800138 H800532 H800885 H802026 H803848 H803945 H804025 H804118 H804215 H804296 H804374 H804465 H804545 H800141 H800537 H800887 H802030 H803849 H803948 H804027 H804119 H804216 H804298 H804375 H804466 H804547 H800143 H800538 H800888 H802032 H803852 H803949 H804028 H804120 H804217 H804299 H804376 H804468 H804548 H800147 H800541 H800913 H802033 H803853 H803951 H804029 H804121 H804218 H804300 H804377 H804471 H804549 H800181 H800542 H800919 H802034 H803855 H803954 H804030 H804122 H804220 H804302 H804380 H804473 H804551 H800194 H800545 H800920 H802035 H803857 H803955 H804033 H804123 H804221 H804305 H804382 H804474 H804552 H800195 H800555 H800923 H802036 H803859 H803958 H804034 H804124 H804222 H804308 H804383 H804476 H804554 H800198 H800566 H800925 H802038 H803860 H803959 H804036 H804125 H804227 H804309 H804384 H804477 H804555 H800202 H800567 H800929 H802057 H803863 H803960 H804037 H804128 H804228 H804310 H804386 H804479 H804556 H800219 H800574 H800947 H802058 H803865 H803963 H804038 H804129 H804229 H804311 H804387 H804482 H804557 H800220 H800575 H801325 H802061 H803866 H803964 H804039 H804132 H804230 H804312 H804388 H804483 H804558 H800227 H800580 H801336 H802062 H803869 H803965 H804044 H804135 H804232 H804314 H804390 H804484 H804560 H800231 H800585 H801460 H802069 H803870 H803966 H804045 H804136 H804233 H804315 H804392 H804485 H804561 H800238 H800586 H801805 H802070 H803871 H803967 H804047 H804137 H804234 H804316 H804393 H804487 H804563 H800241 H800598 H801806 H802072 H803872 H803968 H804049 H804138 H804235 H804317 H804394 H804488 H804565 H800242 H800600 H801807 H802073 H803873 H803969 H804050 H804140 H804238 H804319 H804395 H804489 H804566 H800252 H800602 H801813 H802079 H803875 H803970 H804051 H804141 H804239 H804320 H804396 H804491 H804567 H800257 H800614 H801819 H802086 H803876 H803971 H804052 H804142 H804240 H804321 H804402 H804492 H804568 H800260 H800616 H801824 H802087 H803879 H803973 H804053 H804143 H804241 H804322 H804403 H804493 H804569 H800265 H800617 H801845 H802092 H803880 H803974 H804054 H804144 H804242 H804323 H804407 H804494 H804570 H800271 H800618 H801849 H802094 H803883 H803975 H804055 H804146 H804243 H804324 H804408 H804495 H804572 H800274 H800625 H801851 H802096 H803884 H803977 H804056 H804147 H804244 H804325 H804414 H804497 H804573 H800278 H800626 H801856 H802097 H803885 H803978 H804059 H804148 H804245 H804326 H804415 H804500 H804574 H800296 H800632 H801863 H802100 H803886 H803979 H804060 H804149 H804246 H804327 H804416 H804501 H804575 H800298 H800634 H801869 H802101 H803887 H803981 H804063 H804150 H804247 H804329 H804417 H804502 H804576 H800315 H800637 H801874 H802105 H803889 H803982 H804064 H804151 H804251 H804330 H804418 H804503 H804577 H800327 H800638 H801889 H802107 H803890 H803983 H804066 H804156 H804253 H804331 H804419 H804505 H804580 H800333 H800641 H801912 H802110 H803893 H803984 H804068 H804159 H804254 H804332 H804420 H804508 H804581 H800335 H800643 H801915 H802111 H803894 H803985 H804070 H804160 H804255 H804333 H804422 H804510 H804584 H800339 H800646 H801916 H802112 H803896 H803986 H804071 H804161 H804256 H804334 H804424 H804511 H804586 H800343 H800648 H801917 H802116 H803897 H803987 H804072 H804162 H804257 H804335 H804425 H804512 H804588 H800419 H800654 H801926 H802118 H803898 H803988 H804073 H804163 H804259 H804338 H804426 H804513 H804589 H800421 H800655 H801934 H802133 H803900 H803989 H804074 H804165 H804261 H804339 H804427 H804515 H804591 H800423 H800660 H801935 H802283 H803901 H803990 H804080 H804166 H804262 H804340 H804428 H804516 H804592 H800425 H800662 H801938 H802402 H803904 H803991 H804081 H804167 H804264 H804341 H804429 H804517 H804599 H800429 H800665 H801940 H802925 H803905 H803993 H804083 H804168 H804265 H804342 H804430 H804518 H804600 H800434 H800670 H801942 H803043 H803907 H803994 H804084 H804172 H804266 H804343 H804431 H804519 H804601 H800435 H800679 H801943 H803382 H803908 H803995 H804085 H804175 H804267 H804344 H804432 H804520 H804602 H800438 H800689 H801944 H803608 H803910 H803997 H804087 H804176 H804268 H804346 H804434 H804521 H804606 H800444 H800690 H801945 H803806 H803911 H803998 H804089 H804177 H804270 H804347 H804438 H804522 H804607
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated December 1, 2011. Firm initiated recall is ongoing.
REASON
An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.
VOLUME OF PRODUCT IN COMMERCE
1486 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog number: 502501. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. Recall # Z-0517-2012
CODE
Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Research Triangle Park,NC, by letter dated December 2, 2011.
Manufacturer: Teleflex Medical, Perak, Malaysia. Firm initiated recall is ongoing.
REASON
Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.
VOLUME OF PRODUCT IN COMMERCE
73,381 units
DISTRIBUTION
Nationwide and Canada and Europe

PRODUCT
  1. GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0584-2012;
  2. GE Healthcare Discovery XR650, Digital Radiographic Systems. System ID SLQDSC1. Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Auto positioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications. Recall # Z-0585-2012
CODE
  1. 205801KDEF1 734671DEF1 205801KDEF2 336716BCR4 907580RM5 305325SM1 252847DEF6 313745ORTHO1 540536DRAD2 OCPINED8K 614566DR1 808951XRDB 315376D8K 843789VR2 419621DR 313745ORTHO2 734998ORTHO1 361572MOBD8K 478MORTHOD8K 720494D8K 559SKDHD8K 734647DEF1 SLQDEF1 212533DEF 484565DEF2 808951XRDA SCOIVALD8000 210617H122 208422D8000 512268D8000 954265ME4 216844XRD1 706721MDR2 717763MPXRD1 SLPDEF1 NYPHC370913 603225DRAD 225358DEF1 708364D8K 708202D8K2 NYPHC370910 847688DX2 928757DR3 252ECHI8K 970DOA8K 856355DEF NYPHC370911 850416DXR NYPHC370914 NYPHC370912 503387D8K 419424DR 704323M8K 315338D8K 215823DEF1 828696RM1 617739RM1D1 MCCD8K 915564DRAD 573632CROR1 304256DEF 501868ACHBR 801285DR1 937296D8K 865429DR1 908522DIF 610526DEF1 330477XRD 813844USFR1 205949DEF1 360417SQRAD1 412688RM2 330543DR1 815525DEF8K 908668DIF 216844MSIXRD2 732294DIF 650474SNCTHU5 360417SQRAD1 216844MSIXRD 617754XRD2A 210208ER 573875CRM4 712264DF8000 314577CGRM3 313745PDDEF OAASPINE 706494HC1 503216XRD1 303340DXR 814234RAD5 717761XRD1 313745ERDEF 920885DXRD 617414ACC2 239593OTS 440974XRD3 210593RAD1 573875CRM4 210396XRD1 949219RAD OAAIMAGE 706494HC2 210804RAD1 641422RM5 617667ORTHO1 412749DEF8000 814234RAD7 617667DR6 617414ACC4 217383CDEF1 617724XR2A2 504868DF 706494HC4 210489RAD1 904WSRAD1 610954DEF 904WSER1 614293D8K 601984XRD1 330455XRD 608392DEF1 715839D8000 847437GEXRD1 973971RAD2 717544HCXRD1 717544HCXRD2 432522WCDR1 228809SRER 570621DEF 319272XRD8 903GSER NYPAL240 617726XR1CP4 269789DEFINIUM 608785DEF 920965DEF 305662ER 952746XRD2 716250CH1 610378RM1 630978DEF 757466RM6 ACB21739DEF 903UTD8 850431ER1D 541677MOIDR2 724775DEF 570621DEF2 503216XRD1 412858DEF1 408363VATHU1 719553SCCD8 816234CDR4 765832WC2 901765DR 406782BODR1 305662RM3 864512EDRM2 636947DEFRM2 920965EDEF 410337ER1 801587DX2 NYP404030 801587DX3 304757DEF8000 281274THUNDER 318681SRM1 239432D8000 601968XRD1 801587DX1 228377ER 904996RAD 773STJXRD321 979282THUNDER 513247D8K 816501RAD2 863284XRD 806212DRAD 412647DEF 432685DDR1 202741XRD 718630XRD 206598UDEF245 206598UDEF204 817329D8000 816501RAD3 720225CRXRDX 240566DR1 719333DEFC 305662RM3 610886DX1 913588KUW8K 734671DWS ACB71029DEF NYPMIL3-113 360689DX 210704PDIG1 504896D8K 956323RM3 281477MWXD2 717299XRD1 860659D8000 913696CDR1 419383ORTHO3 225754DEF1 734998BWDEF 419383ORTHO1 610954DEF2 706721MDR1 330486XRD 757722C212 734936DEF1 503513XRD NYPVC113 830331DIG1 478633DF8 207283DEFRAD1 607274DRAD1 334826HCA 661SCOID8000 978774DX1 313343DEF1 973538RAD 863680RM6 2682721 517353DEF1 206598RAD1 419783DR 650696XRD2 614257D8K 614293DR 216778XRD1 920721DEF 617724XR1A2 325670DEF1 206598UDEF247 508941RM11 727767XRAY1 978466DEF1 915747ERRAD 586532D8000 314849SLO1 704783DEF2 781344XRD2 714966RM5 925939ER1 415600CALDEF 704323DEF1 COR381050 850883ER1 541743DR5 M54219 314523OD8K 412647EDR1 949759D8 505265XRM6 813879XRD 602277A2228 505265XRM4 801662DX 906225D8K 207553DEF 229DEF8000 804SMHER2 207779DEF 704783DEF5 904202ORAD 404251DEF1 650474SNCTHU2 417781SJER 281482DR1 732923DIF1 404712DEF1 719SGPDR1 760873RAD 330363R1 212241RAD1 541768RM1 334528EAORTHO 419455DR 406457HODR1 920406DEF 330558D8 734936DEF2 650497SHTHU1 216791XRD1 617889XR1CH 734930MSDEF 541267DR1 623327D8000 412784VADEF 650474SNCTHU4 573814VARAD1 407VADEF1 303399XRD8K HIP816DEF1 415UCDEFORTHO 619532DEF15 650474SNCTHU1 251415RAD 724836DEF1 321841DEF1 503732XRD 913588KD8K 281274MSD8000 904399CHEST 859313DEFB 732776D8K 812343DEF1 614293SRDR 706733VAUD2 609219D8K 704323DEF2 409839D8000 920725DEF 301295DEF8 925939ER2 SPINEDEF1 706322SFSC 517353DEF2 210638RAD3 412692ORTHO2 706787ORTHO 650474SNCTHU6 650474SNCTHU3 717544HPXRD1 JAC2W11 303651DEF2 757388RP3 706733VR6 217326CCH2 509837SDEF 337234LBJ1 503VAHD8K 412692R1 206764DEF 713441ORTHORAD 808433D8KRM4 425455PROORTHO 734998ORTHO2 404321DEF1 720225LMCD8K 239768RM1 386FHOR1 508422DEF4 210617H104 724772DEF1 218722DEF 425392PRO1 360414XRD1 985882RAD1 978XR1NS 813827DEF8K 303321XRD8K 816234COPC 360417RAD1 00100RAD05 00123RAD05 00440RAD16 00454RAD02 00356RAD07 00226RAD08 01059RAD02 00065RAD08 10563RAD03 00065RAD07 00824RAD02 00065RAD06 00521RAD05 10086RAD03 00116RAD04 00324RAD09 AE1010RX04 61007RAD02 61012RAD01 06014RAD02 856070190 426020XR03 K001RX02 M001RX32 M001RX34 O010RX07 K002RX03 CEE15654 DE641219 DEG27409 DE644605 DPN88401 MPX27410 DEN51301 FPG86423 DEN00500 DEN00300 DEN00400 FPG93006 YE626921 DEN00200 DEN00100 DPM32148 DEN00301 DEL89966 DEN00704 DE541A09 DEN00000 DEN01005 DEN00805 DEN00602 DEN01105 EP591318 FEG85904 DEN00611 DEN90700 DPM32147 DPN26321 CEL75708 CEZ08802 CE165327 CEZ04110 CE262911 DEN01708 DE203238 DPL32925 ME504381 UE535A106 NE203136 DPB15839 GEX00400 ZA1000RX05 SA2177RX01 RU1785RX02 RU1646RX03 850070809 850070813 850070760 850070763 850070767 850070773 850070766 850070778 850070751 PER64201 PER18111 PER18410 NO1015RX08 NO1108RX03 NO1052RX08 NO1016RX07 NO1077RX03 920079103 920079105 920079110 RTD0986 MQ1000RX09 JO1000RX02 WX0102 WX0210 WX0211 XK0102 WX0203 WX0202 WX0201 WX0204 WX0205 WX0206 A5102680 A5356251 A5300722 B5300707 A5115127 A5624113 B5120721 A5804416 A5814918 A5238814 A5317201 A5317202 A5164518 A5128409 C5237807 B5127421 IL1062XR11 IE1044RX01 IE1044RX02 IE1111RX01 828070118 828070120 828070121 828070125 828070124 828070109 828070113 828070117 H2009RAD35 UHAN01XR13 HC0881XR04 HROS01XR03 487692XR02 PC0362XR07 HC7048XR05 519926XR03 561559XR02 HC0399XR08 PC6132XR07 PF1000RX11 M4168064 X59007318 A4192906 P4211488 M4187723 M4202413 M1966307 B4191737 M4472226 M4195131 M4211061 M4215549 A1717401 M9164773 M2717507 M177858601 A4167326 X1135601 M4484739 M4135317 M4173815 B4195724 M4168125 M4171226 M4185525 M4467029 A190136602 M5484954 A2035104 FI1052RX02 FI1144RX01 FI1017RX01 FI1133RX01 DK1043RX03 CS1004RX05 CS1090RX02 CS1013RX07 CS1013RX06 CS1138RX01 CS1013RX08 82407210082 82407250068 82407130221 82407040419 82407070112 82407160269 82407070114 82407040429 082407120178T 82407160279 82407040366 82407040371 82407040372 82407040373 82407040374 82407040384 82407160242 82407040398 82407040393 82407160244 82407070117 82407120178 27305DEF 27305DEF2 416813DEF8000A 905883DEF3 905883DEF1 905883DEF2 902473DEF1 514338DEF2 514338DEF3 519646DEF1 709778ADEF1 709778DEF1 519534XRD2D 416756D8000 416284DEF 519376XRD1 506452RM2A 519986RAD 519376XRD2 905522DEF 519797DEF 416284DEF2 519538RAD2 204787DEF 204787DEF2 416469DEF2 514473DEF 709637DEFINIUM 506375DEF1 416469DEF2 604557RAD4 403639RAD1 604557RAD1 604557RAD3 905848DEF1 403349ARAD2 416323DEF 905848DEF2 905895DEF 506857DEF1 418276DEF8000 514431DEF 709737RAD5 709737RAD4 030240RX04 030419RX08 190059RX20 220078RX30 080041RX14 AH3403XR03 AH6834XR02 AP4502XR08 AP3408XR10 910072181 910074017 910072141 910092229 910073084 910073085 910072169 910074018 910074022 910074021 1821DEF80 3882754403XRMET;
  2. 414649DIS650 603668C6 704323M650 843789VR1 202865XRD650 727581DC650 508693MVDR 423624DIS6 412367MPI 832505DR1 713873BONE1 734462LIVXR1 423624DEF8 614722D650 OCMATT650 704323U650 650497CHDIS1 908685D650 540498RM2 203694ER650A 605226XR650 651439XR650 573884XR2 573884XR1 573884XR3 281477MW650XR1 281477MW650XR2 713441MM650 605719XR650 716631DRAD1 309655FXR3 3026291 320202XR650 303PSL650 573884XR4 412367D650 415CPSUTDEF2 650MPXR6502 734998BW650 VALLCXR650 615349RM2 417625OPD 832505DR3 814375RM1 832505DR2 315787RAD1 443481SJK1 616267XR650A 913696CDR2 623251DR1063 650MPPAMOB 860749XR650 386FHDVR1 281MWXR6501 812482DR1 818364ER 617SHLL515 617SH4333 205933DXR 307773D650 413748RAD6 614722D650R2 504842RM2 802773D650 520DMXR650 915742DRAD1 301295XR650 210358DIG1 313576XR650 415221VA650 SLH650 810494D650A LLPMXR650R2 NYPAL172 814788D650 706733VR4 516608D650 ORMCXR380 816234CDR5 SLHWG650 ORMCXR386 443481ED2 409761PCP2 970395XR650 571231DX2 810494D650B 508334DRAD 573875XR3 650MPPAMF2 210358UCCHRM1 310319DISCXR5 310319DISCXR4 412623ER1 816234COPC1 310319DISCXR3 310319DISCXR2 585596DRAD 409761PCP1 301765RAD 719285XR650 406495SPDR1 816960CDR1 309655GPR1 415UCMBD6501 415UCMBD6502 0002852904BX 573815BR2D 920830RAD2 708202D650 713441MO650 908522D650 281STLV6501C143 504842RM1 601936ERXRD ORMCER2 ORMCER1 504349R9 571231DX1 609247RAD1 SLRBONE 00216RAD14 00001RAD11 00440RAD23 00424RAD06 AE1016RX10 AE1016RX09 856070221 S001RX08 M001RX40 M001RX39 ME051547 SA1011RX10 SA1056RX02 SA1012RX19 SA2191RX03 SA1008RX01 SA2235RX01 SA2249RX01 SA2191RX05 SA2244RX01 SA1056RX03 SA2253RX01 SA1056RX04 SA1011RX11 SA2240RX01 850070828 850070841 850070840 NO1051RX02 WV0301 WV0151 WV0201 WV0160 WV0251 WV0206 WV0210 WV0154 WV0303 WV0302 WV0304 WV0153 WV0208 WV0254 WV0209 WV0253 WV0152 A5604844 A51272107 A51026100 A51026102 828070123 PHAM02XR04 PP0034XR02 HC9059XR03 HC2636XR02 558739XR03 A4194835 M4173034 M4206219 M4008407 M2348213 M4461517 M23084302 M23084301 M1656626 B6010815 M4200018 M4196643 FI1128RX02 EE1016RX01 82407110065 82407040425 82407040432 82407100420 82407220044 82407040436 82407040447 82407100410 82407040431 82407110068 82416300005 82407300033 82407090149 506357RAD1 604869XR 905527DEF4 905527DEF2 613548RAD1 905527DEF1 604582XR2 604582XR1 250339XR1 250370XR1 514765XR650 250746XR1 905521XR650A 514934BRAD3 418689XRD 418547XR1 BA4080RX02 BA4017XR04 030220RX14 910073103 910072201 910074030 910075020 910072215
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha,WI, by letter dated November 17, 2011. Firm initiated recall is ongoing.
REASON
The patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. This could permit the arm to swing freely when the rotating arm locking lever is released. Should this happen during use, injury to the patient and/or user could occur.
VOLUME OF PRODUCT IN COMMERCE
911 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
  1. DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE. The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0586-2012;
  2. DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0587-2012;
  3. DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0588-2012;
  4. DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0589-2012;
  5. DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis. Recall # Z-0590-2012
CODE
  1. Lot C28712;
  2. Lots 500137, 500138, 527756, C28713;
  3. Lots 500139, 527573, 527755, C28714;
  4. Lots 527842, C28715;
  5. Lots 523908, 527961, C28716
RECALLING FIRM/MANUFACTURER
AngioDynamics, Inc., Queensbury, NY, by letter dated January 28, 2011. Firm initiated recall is ongoing.
REASON
AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.
VOLUME OF PRODUCT IN COMMERCE
1124 units
DISTRIBUTION
Nationwide

PRODUCT
  1. Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our devices within an outer container. Removal of the wipes will not compromise the sterile barrier of our device and can easily be identified and replaced. Recall # Z-0592-2012;
  2. IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Recall # Z-0593-2012
CODE
  1. Catalog # Lot # B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852; B7932: 2010961, 2012567, 2012965, 2022800; M1861: 1724481 M2461: 1701070; M2491: 1706450; M3060: 1711976; M3091: 1701069; M4261: 1711981; P1005: 1992939; P1850: 1887213; P1851: 1646310, 1646311, 1750036, 1863485, 1887212, 1972548, 2013176; P1861: 1385494, 1711980, 1752814; P1881: 2027824; P1891: 1471913; P2450: 1800862; P2451: 1598200, 1598201, 1598206, 1750038, 1800860, 1815008, 1851423, 1887209, 1887216, 1972553; P2460: 1470415, 1722014; P2461: 1087509, 1385394, 1598097, 1774378, 1803640, 1848045, 1971554, 2022098; P2481: 1999027, 1999484, 2022794, 2027826; P2491: 1363050, 1557296, 1692396, 1782845; P3051: 1366012, 1646308, 1646312, 1660580, 1660581, 1800858, 1841693, 1853574, 1887208, 1887215, 1887217, 1972556, 2027827; P3061: 1062302, 1087495, 1686643; P3081: 1919294, 1972551, 1978024, 2027828; P3091: 1244139, 1244140, 1244141, 1363051, 1598101, 1598102, 1686641, 1686644; P4251: 1646309, 1646313, 1871643, 2022795; P4260: 1439395; P4261: 1363053, 1722015; P4281: 2027825, 2045107; P4290: 1439397; P4291: 1363049, 1722019, 1761743, 1774372, 1774374, 1774375, 1774376, 1774377, 1774379, 1774380, 1782841, 1782842, 1782843, 1782844, 1799794, 1799795, 1799796, 1799797, 1799798, 1814994, 1848046, 1855183, 1972546, 2007344, 2027816. P4291M: 1863467, 186468, 1863469, 18687998, 1887999, 1888000, 1888001, 1888002, 1888003, 1888004, 1888005, 1888006, 1972538, 1972539, 1972542, 1975233, 1990393, 1990395, 1991948, 2006952, 2006953, 2006954, 2006955, 2007432, 2022118, 2026307, 2026308, 2026309, 2027903, 2027904, 2028415;
  2. Catalog # : Lot # B7825: 253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120, 253125, 253130, 253144, 253183, 253199, 253216, 253226, 253234, 253245, 253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341, 253348, 253363; B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC, 253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087, 253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133, 253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171, 253177, 253181, 253187, 253188, 253190, 253194, 253196 253198, 253200, 253205, 253207, 253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238, 253243, 253246, 253251, 253254, 253255, 253257, 253262, 253264, 253272, 253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299, 253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336, 253338, 253342, 253350, 253351, 253356, 253358, 253366, 253370, 253372, 253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401, 253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432, 253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470, 253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500, 253502, 253505, 253512, 253519, 857-SC4; B7841: 233163, 253028-SC, 253033-SC, 253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101, 253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156, 253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236, 253242, 253247, 253253, 253261, 253271, 253274, 253279, 253282, 253289, 253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333, 253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 , 253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425, 253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477, 253480, 253486, 253492, 253504, 253506, 253511, 253515, 253521, 253530; B7842: 20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142, 253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249, 253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380, 253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481, 253487, 253493, 253503, 253535; B7844: 253047-SC; B7846: 253513; B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226, 253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178, 253197, 253213, 253241, 253265, 253285, 253303, 253310, 253325, 253337, 253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1; B7928: 213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC, 253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145, 253151, 253158, 253173, 253176, 253186, 253193, 253201, 253206, 253209, 253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260, 253268, 253277, 253287, 253291, 253296, 253306, 253312, 253317, 253323, 253330, 253334, 253340, 253345, 253349, 253353, 253359, 253368, 253371, 253382, 253389, 253393, 253398, 253404, 253408, 253416, 253424, 253429, 253433, 253442, 253448, 253454, 253460, 253464, 253471, 253478, 253483, 253488, 253494, 253497, 253501, 253507; B7932: 2010961, 2012567, 2012965, 2022800; B7937: 253355, 253362, 253377, 253394; B7938: 253354, 253361, 253378, 253395; Z0125: 78-458-YJ; Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5, 63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A, 69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5, 76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN, 92-782-R5, 94-196.2A, 94-196-2A; Z8017: 61-577-K4, 63-347-SN, 64-194-2A, 64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A, 81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5, 93-166-LA; Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ, 64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5
RECALLING FIRM/MANUFACTURER
ICU Medical, Inc., San Clemente,CA, by letter dated March 2, 2011. Firm initiated recall is ongoing.
REASON
The Triad alcohol prep pads have the potential contamination of the bacteria, Bacillus cereus. The Triad Group alcohol prep pads have been copackaged and distributed with ICU Medical Orbit subcutaneous infustion sets, Orbit Micro subcutaneous infusion sets, and IV Start kits. This recall involves those products marked as sterile as well as non-sterile.
VOLUME OF PRODUCT IN COMMERCE
957,990 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
  1. Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0647-2012;
  2. Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5 each --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. Recall # Z-0648-2012
CODE
  1. Lots: 1ML0052506, 1ML0062201, 1ML0080901;
  2. Lots: 1ML0060705, 1ML0070901, 1PD0040501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Navilyst Medical, Inc., Glens Falls, NY, by letter dated February 4, 2011.
Manufacturer: Navilyst Medical, Inc., Glens Falls,NY;
Medventure Technology Corp., Jeffersonville,IN. Firm initiated recall is complete.
REASON
The Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
VOLUME OF PRODUCT IN COMMERCE
118 boxes
DISTRIBUTION
Nationwide and South Africa

PRODUCT
  1. Weck, DuraHook (6mm) and (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog numbers: 382800. Recall # Z-0677-2012;
  2. Weck, DermaHook(12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater. Catalog number: 382805. Recall # Z-0678-2012
CODE
  1. Lot numbers: 01A1100009, 01A1100165, 01A1100251, 01A1100355, 01B1100028, 01B1100274, 01E1000297, 01F1000587, 01F1000588, 01F1000589, 01G1000138, 01G1000327, 01G1000433, 01G1000512, 01H1000112, 01H1000297, 01J1000548, 01K1000182, 01M1000218, 01M1000326 and 01M1000339;
  2. Lot numbers: 01A1100470, 01A1100374, 01A1100517, 01A1100519, 01B1100006, 01B1100131, 01B1100159, 01B1100275, 01E1000026, 01F1000586, 01G1000137, 01G1000139, 01G1000251, 01G1000326, 01H1000271, 01H1000296, 01J1000267, 01J1000298, 01K1000005, 01K1000051, 01K1000181, 01K1000334, 01L1000282, 01L1000283, 01L1000292, 01M1000008, 01M1000144, 01M1000198, 01M1000199 and 01M1000200
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Research Triangle Park,NC, by letter dated December 6, 2011.
Manufacturer: Teleflex Medical, Tecate, Mexico. Firm initiated recall is ongoing.
REASON
Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.
VOLUME OF PRODUCT IN COMMERCE
296,580 units
DISTRIBUTION
Nationwide

PRODUCT
NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM. Part Numbers: 828-050000, 828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100, 828-063200, 828-063300, 828-063500. Recall # Z-0737-2012
CODE
NicVue Software version 2.9.2 and 3.0.1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: CareFusion 209 Inc., Middleton,WI, by letter dated December 16, 2011.
Manufacturers: CareFusion 209 Inc., Middleton, WI;
VIASYS Healthcare-Intermed Precision Subsidiary, Galway, Ireland. Firm Initiated recall is ongoing.
REASON
CareFusion recently discovered that NicVue versions 2.9.2 and 3.0.1 contains a software issue that may affect some workflows. To prevent this possibility, your NicVue version 2.9.2 must be updated to 2.9.3 and 3.0.1 must be updated to NicVue version 3.0.2. Under certain work flow processes, when selecting a new patient name in NicVue, the associated exams list may not properly refresh, and may continue to display the previous patient's exams. When the exam record is opened in the device application software, the correct patient name associated with that record is displayed at the top of the screen, but it may not be the intended patient's record.
VOLUME OF PRODUCT IN COMMERCE
1676 (614 Nationwide; 1062 Internationally)
DISTRIBUTION
Nationwide and Internationally

PRODUCT
Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101). The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures; Catalog # 900103. Recall # Z-0830-2012
CODE
Lot # 0253304, Exp Date. 09/2013; Lot # 0298222, Exp Date 10/2013; Lot # 0298223, Exp Date 10/2013; Lot # 0308031, Exp Date 11/2013; Lot # 0312202, Exp Date 11/2013; Lot # 0330293, Exp Date 11/2013; Lot # 0344197, Exp Date 12/2013; Lot # 0351244, Exp Date 12/2013; Lot # 0351245, Exp Date 12/2013; Lot # 1007208, Exp Date 01/2013; Lot # 1014335, Exp Date 01/2013; Lot # 1126136, Exp Date 05/2013; Lot # 1175144, Exp Date 06/2013; Lot # 1189159, Exp Date 07/2013 & Lot # 1203154, Exp Date 07/2013. Catalog # 900101 - Lot #, 0314042, Exp Date, 11/2013; Lot #, 0323224, Exp Date, 11/2013; Lot #, 0356041, Exp Date, 12/2013; Lot #, 1007265, Exp Date, 01/2013; Lot #, 1119054, Exp Date, 04/2013 & Lot #, 1133140, Exp Date, 05/2013
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Cincinnati OH, by letter dated October 11, 2011. Firm initiated recall is ongoing
REASON
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
VOLUME OF PRODUCT IN COMMERCE
187,400 units (900103 syringe: 129,200; 900101 syringe: 58,200)
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III

PRODUCT
  1. 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0153-2012;
  2. 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0154-2012;
  3. 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0155-2012;
  4. 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0156-2012;
  5. 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. Recall # Z-0157-2012
CODE
All lots produced since April 2007
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation and Pentron Clinical, Orange, CA, by letter dated May 31, 2011. Firm initiated recall is ongoing.
REASON
The product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.
VOLUME OF PRODUCT IN COMMERCE
41,744 units
DISTRIBUTION
Nationwide and Internationally

PRODUCT
Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures. Catalog number 7501669. Recall # Z-0806-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated December 12, 2011.
Manufacturer: KeyMed (Medical and Industrial Equipment) Ltd. Southend-On-Sea, UK. Firm initiated recall is ongoing.
REASON
Water may leak from the irrigation tubing used on the Olympus Flushing Pump.
VOLUME OF PRODUCT IN COMMERCE
64,667 packages of 10 irrigation tubes
DISTRIBUTION
Nationwide

PRODUCT
NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx. The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician. Recall # Z-0826-2012
CODE
Lot 1117911, Exp. 2013-09
RECALLING FIRM/MANUFACTURER
Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by telephone on December 13, 2011, and by letter dated December 14, 2011.
Manufacturer: Medimexico, S. de R.L. de C.V., Tijuana, Mexico. Firm initiated recall is on going.
REASON
Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System.
VOLUME OF PRODUCT IN COMMERCE
1,192 devices (596 cases containing 2 SAKs)
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR JANUARY 25, 2012.
 
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