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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 4, 2012

 

April 4, 2012                                                                                               12-14
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
VitaFlo Renastart, Net Wt 400g (14.11 oz), UPC 5060014054623. Recall # F-0954-2012
CODE
Batch number 12832
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vitaflo USA, Alexandria, VA, by letters on January 28, 2012 and press release on January 30, 3012. 
Manufacturer: Fayrefield FoodTec Ltd, Crewe, Cheshire, UK. Firm initiated recall is ongoing.
REASON
Cans of Renastart may have been mislabeled.
VOLUME OF PRODUCT IN COMMERCE
2190 cans
DISTRIBUTION
Nationwide
________________________________
PRODUCT
1) Whey Protein Isolate, 90%, packaged in 1500 lb Supersacks and 20 kg Kraft lined bags. Recall # F-0958-2012;
 
 2) Whey Protein Hydrolysate, 90%, Packaged in 20 kg Kraft lined bags. Recall # F-0959-2012
CODE
1) Lot #: J1360, J1361, J1364, J1365, J2015, J2026, J2027, J2028, J2029, J2030, J2034, J2035, J2036, J2037, J2038;
 
2) Lot #: J1364, J2034
RECALLING FIRM/MANUFACTURER
PGP International, Inc., Juda, WI, by telephone or email and a follow-up letter on March 15, 2012. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
127,335 lbs
DISTRIBUTION
IL, MD, MI, MN, WI
___________________________________
PRODUCT
1) Let's Grow Healthy Together Alfalfa Sprouts 5 oz, UPC 714722228818; Green Valley Food Corp. Alfalfa, 4 oz container, UPC 815098001088. Recall # F-0969-2012;
 
2) Let's Grow Healthy Together Spicy Sprouts, 5 oz container, UPC 714722229914; Recall # F-0970-2012;
 
3) Green Valley Food Corp. Onion Sprouts a blend of alfalfa and onion sprouts, 4 oz., UPC 815098002054. Recall # F-0971-2012;
 
4) 5 oz product label: Let's Grow Healthy Together! Sunflower Greens, 5 oz. container, UPC 714722206069, 1 lb bags: Product is packaged in a clear bag with no labeling. Bags are placed into plain brown boxes with no labeling. Recall # F-0972-2012;
 
5) 5 oz containers: Let's Grow Healthy Together! Clover Sprouts, 5 oz. container, UPC 714722225510, 2 lb packages are packaged in clear plastic bags with white stick-on label that reads "Green Valley Food Corp. 2 lb. Clover". Bags are placed into plain brown boxes with no labeling. (no UPC). Recall # F-0973-2012;
 
6) Let's Grow Healthy Together! Onion Sprouts, 2 oz container, UPC 714722227712. Recall # F-0974-2012;
 
7) Let's Grow Healthy Together! Zesty Sprouts, 5 oz container, UPC 714722221116. Recall # F-0975-2012;
 
8) Let's Grow Healthy Together! Organic Wheat Grass, 6 oz, UPC 714722608122; Green Valley Food Corp. Organic Wheatgrass, 4 oz, UPC 714722608122; 9 lb. container, packaged in a brown cardboard box labeled as "Green Valley Let's Grow Healthy Together!" Recall # F-0976-2012;
 
9) Let's Grow Together! Mung Bean Sprouts 8 oz, UPC 714722208087, Let's Grow Healthy Together! Mung Bean Sprouts, 8 oz, UPC 815098001071 Green Valley Food Corp. Let's Grow Healthy Together! Mung Bean Sprouts 16 oz., UPC 714722208162. Recall # F-0977-2012;
 
10) Green Valley Food Corp. Spicy Sprouts a blend of clover and radish sprouts, 4 oz container, UPC 815098002023. Recall # F-0978-2012;
 
11) 3 oz container: Green Valley Food Corp. 100% Snow Pea Shoots, 3 oz container, UPC 714722106062, 1 lb container is a clear plastic, 1 lb bag in a plain brown paper box. Recall # F-0979-2012;
 
12) 3 oz container: Green Valley Food Corp. 100% Daikon Sprouts, 3 oz container, UPC 714722206076, 5 oz container: individual product is in a clear bag, each case is labeled as Daikon Sprouts 12/5 oz Keep refrigerated (no UPC). Recall # F-0980-2012;
 
13) Broccosprouts Sandwich Blend broccoli & clover sprouts, 4 oz. container, UPC 815098000289. Recall # F-0981-2012;
 
14) Broccosprouts Salad Blend broccoli, clover, & radish sprouts, 4 oz container, UPC 815098000265. Recall # F-0982-2012;
 
15) Broccosprouts Deli Blend, 4 oz containers, UPC 815098000272. Recall # F-0983-2012;
 
16) Broccosprouts broccoli sprouts, 4 oz containers, UPC 815098000258. Recall # F-0984-2012;
 
17) Green Valley Food Corp. 2lb. Alfalfa (Contain Clover). Recall # F-0985-2012;
 
18) 1 lb container of Soybean Sprouts are packaged in a clear plastic bag inside of a plain brown cardboard box. 5 lb and 10 lb containers are packaged in a clear plastic bag inside of a brown cardboard box labeled as follows: "Green Valley LET'S GROW HEALTHY TOGETHER! FRESH SPROUTS. Recall # F-0986-2012
CODE
Products have a use by date of 12/22/11 - 01/17/2012
RECALLING FIRM/MANUFACTURER
Green Valley Food Corp., Dallas, TX, by letters on December 22, 2011 and December 24, 2011, and by press releases on December 22, 2011, December 24, 2011, December, 31, 2011, and January 3, 2012. FDA initiated recall is ongoing.
REASON
The products have the potential to be contaminated Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
242,355 pounds
DISTRIBUTION
TX, LA
___________________________________
PRODUCT
Whole Foods Market BakeHouse Mini Chocolate Chip Cookies packaged in a small brown paper bag, with a clear window and a chocolate chip cookie label on the front. The sell-by date and UPC number are printed on the back label of the bag. 480 pieces per case.
UPC code: 2-21485-20399-5 and manufacturing dates of 03/02-21/2012. Recall # F-0987-2012
CODE
Lot # 0229
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market, Austin, TX, by press release on March 22, 2012 and email on March 21, 2012.
Manufacturer:Whole Foods Market Houston Bakehouse (HBH), Houston, TX. Firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
40 cases of 480 (1 oz) cookies
DISTRIBUTION
AR, LA, OK, and TX
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
________________________________
PRODUCT
"***labuenapesca***Shark Cubes (Tiburn para pinchos)*** 1 lb (16 oz) Net Weight***Product of Peru***Keep frozen". Recall # F-0956-2012
CODE
Prod. date: 06/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sea World, Inc., Guaynabo, PR, by telephone and letter on January 20, 2012.
Manufacturer: Sercosta Sac, San Isidro, Peru. FDA initiated Recall is ongoing.
REASON
The product is off odor, off taste, and found to be decomposed based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
119 boxes
DISTRIBUTION
Puerto Rico
___________________________________
PRODUCT
Market Basket Solid White Albacore Tuna in Water, 5 oz. 1230SM/SKU 507560 - UPC 4970502020. Recall # F-0957-2012
CODE
Best buy dates of August 18, 2014 and August 19, 2014
RECALLING FIRM/MANUFACTURER
StarKist Co., Pittsburgh, PA, by telephone on December 21, 2011 and press release on December 22, 2011. Firm initiated recall is ongoing.
REASON
Product contains undeclared hydrolyzed soy protein.
VOLUME OF PRODUCT IN COMMERCE
9,054 cases
DISTRIBUTION
MA, NH
___________________________________
PRODUCT
a) Valu Time Solid Pack Pumpkin, 29 oz can, UPC 1122506619 and b) Food Club Solid Pack Pumpkin, 29 oz can, UPC 3680089519. Recall # F-0960-2012
CODE
a) 3200/01009, best by 06/17/2014 SEI NGJ, sell by 6/17/2014; 3200/01009, best by 07/13/2014 SEI NGJ, sell by 7/13/2014and; b) 3200/01009, best by 07/13/2014 SEI NGJ, sell by 7/13/2014
RECALLING FIRM/MANUFACTURER
Giant Eagle, Pittsburgh, PA, by letter on November 22, 2011 and on November 23, 2011. Firm initiated recall is ongoing.
REASON
Product did not meet Giant Eagle's quality standards.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OH, PA, WV, IL
___________________________________
PRODUCT
1) Raspberry Scuffin (scone/muffin) labeled in part: "Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) RASPBERRY SCUFFIN INGREDIENTS: enriched bleached wheat flour (niacin, iron thiamine, mononitrate & riboflavin) water, raspberries, powdered sugar (sugar, corn starch) buttermilk solids, soybean oil, dextrose, brown sugar, leavening (sodium bicarbonate, sodium acid, pyrophosphate, monocalcium sulfate), eggs pure vanilla, salt, possible tree and ground nut residue." Recall #F-1022-2012;
 
2) Orange Cranberry Oat Scuffins (scone/muffin) labeled in part: "Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) ORANGE CRANBERRY OAT SCUFFIN INGREDIENTS: enriched bleached wheat flour (niacin, iron thiamine, mononitrate & riboflavin) water, oats, orange juice concentrate, buttermilk solids, partially hydrogenated soy beam oil, dextrose, cranberries (cranberries, sugar, sunflower oil), brown sugar, eggs, pure vanilla, orange zest, leavening (sodium bicarbonate, sodium acid, pyrophosphate, monocalcium sulfate), salt, possible nut residue." Recall #F-1023-2012;
 
3) Blueberry Scuffin (scone/muffin) labeled in part: "Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) BLUEBERRY SCUFFIN INGREDIENTS: enriched bleached wheat flour (niacin, iron thiamine, mononitrate & riboflavin) water, blueberries, powdered sugar (sugar, corn starch) buttermilk solids, soybean oil, dextrose, brown sugar, leavening (sodium bicarbonate, sodium acid, pyrophosphate, monocalcium sulfate), eggs pure vanilla, salt, possible nut residue." Recall #F-1024-2012;
 
4) Double Chocolate Scuffin (scone/muffin) labeled in part: *"Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) DOUBLE CHOCOLATE SCUFFIN." The rest of the violative label was not available. Recall #F-1025-2012;
 
5) Lemon Poppyseed scuffin (scone/muffin) labeled in part: *"Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) LEMON POPPYSEED SCUFFIN." The rest of the violative label was not available. Recall # F-1026-2012;
 
6) Marionberry scuffin (scone/muffin) labeled in part: *"Gramma Jan's Sweet Sensations NET WT 5 oz (143.7g) MARIONBERRY SCUFFIN INGREDIENTS: enriched bleached wheat flour (niacin, iron thiamine mononitrate & riboflavin) water, marionberries, powdered sugar (sugar, corn starch) buttermilk solids, soybean oil, dextrose, brown sugar, leavening (sodium bicarbonate, sodium acid, pyrophosphate, monocalcium sulfate), eggs, pure vanilla, salt, possible tree & ground nut residue." Recall # F-1027-2012;
 
7) Four ounce and ten ounce caramel corn labeled: *"Gramma Jan's Sweet Sensations NET WT 4 oz (113g) CARAMEL CORN AIR POPPED & OVEN BAKED INGREDIENTS: Brown sugar, butter (milk, salt) corn syrup, popcorn, molasses, pure vanilla, baking soda, salt, may contain: milk, egg, tree nut, wheat, peanut soy.” The ten ounce size is labeled with "*** NET WT 10 oz (283g)***" *This is the NEW label. The firm could not provide a copy of the old label that did not list milk. Recall # F-1028-2012;
 
8) Four ounce and ten ounce caramel corn labeled: *"Gramma Jan's Sweet Sensations net wt 4 oz (113g) SNICKERDOODLE CARAMEL CORN AIR POPPED & OVEN BAKED INGREDIENTS: Sugar, butter (milk, sweet cream, salt) corn syrup, popcorn, cinnamon, pure vanilla, baking soda, salt, may contain: milk, egg, tree nut, wheat, peanut soy." The ten ounce size is labeled with "*** net wt 10 oz (283g)***" *This is the NEW label. The firm could not provide a copy of the old label that did not list milk. Recall # F-1029-2012
CODE
Most products do not have codes, for those that do have codes it is a best by date that is 15 days past the manufacture date.
RECALLING FIRM/MANUFACTURER
Gramma Jan's Sweet Sensation, Salem, OR, by telephone on February 8, 2012. Oregon initiated recall is ongoing.
REASON
The labels for two varieties of caramel corn did not declare milk as a sub ingredient in butter.
VOLUME OF PRODUCT IN COMMERCE
Scuffins (all six flavors): 264; Caramel Corn (both flavors/sizes): 438
DISTRIBUTION
OR, WA
 
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
NONE
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Acetylcysteine Solution, USP, 20%, packaged in 3 x 30 mL vials per carton, Rx only; NDC 0054-3026-02; Item # 0233-53-1877093. Recall # D-1278-2012
CODE
Lot #1877093, Exp. Date 06/30/2013
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc., Bedford, OH, by letters on December 19, 2011, by press release on February 2, 2012 and letters dated February 3, 2012. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; glass particle identified during review of retain samples.
VOLUME OF PRODUCT IN COMMERCE
4,911 cartons
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Butorphanol Tartrate Injection, USP 1mg/ mL 1mL Single Dose Vial, Rx Only, NDC 0143-9864-10. Recall # D-1276-2012;
 
2) Butorphanol Tartrate Injection, USP 2 mg/mL 1mL Single Dose Vial (NDC 0143-9867-10), Rx Only, NDC 0143-9864-10. Recall # D-1277-2012
CODE
1) Units: 102015.1, 102016.1, 102017.1, 112113.1;
2) Units: 102018.1, 102019.1, 102020.1, 112114.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ, by letter dated January 24,2012.
Manufacturer: Hikma Farmaceutica, (Portugal) S.A., Fervenca, Terrugen, Portugal. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Butorphanol Tartrate Injection is out of specification for impurities at the 18 month room temperature time point.
VOLUME OF PRODUCT IN COMMERCE
21,282 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Heparin Sodium 20,000 Units (40 units/mL) in 5% Dextrose Injection, Rx Only, 500mL Excel Container, NDC 0264-9567-10; a) US Catalog code: P5671; b) Canadian Catalog code: P5671-00. Recall # D-1279-2012;
 
2) Heparin Sodium 25,000 Units (50 units/mL) in 5% Dextrose Injection, Rx Only, 500mL Excel Container, NDC 0264-9577-10. a) US Catalog code: P5771; b) Canadian Catalog code: P5771-00. Recall # D-1280-2012;
 
3) Heparin Sodium 25,000 Units (100 units/mL) in 5% Dextrose Injection, Rx Only, 250mL Excel Container, NDC 0264-9587-20; a) US Catalog code: P5872; b) Canadian Catalog code: P5872-00. Recall # D-1281-2012;
 
4) Heparin Sodium 1,000 Units (2 units/mL) in 0.9% Sodium Chloride Injection, Rx Only, 500mL Excel Container, NDC 0264-9872-10. US Catalog code: P8721. Recall # D-1282-2012
CODE
1) a) Lot #: J1D638N, Exp 10/13; J1N645N, Exp 04/14; b) Lot #: J1D614B, Exp 10/13;
 
2) a) Lot #: J1D587N, Exp 10/13; b) Lot #: J1D629N, J1D695N, J1D697N, Exp 10/13;
 
3) a) Lot #: J1D703N, Exp 10/13; b) Lot #: J1D630N, J1D631N, J1D702N, Exp 10/13;
 
4) Lot #: J1D575N, J1D639N, J1D650N, Exp 10/13; J1E534N, J1E544N, J1E695N, J1E705N, Exp 11/13; J1H522N, J1H523N, J1H590N, J1H591N, J1H601N, J1H602N, Exp 12/13; J1N625N, J1N634N, J1N724N, J1N737N; Exp 04/14; J1S474N, J1S475N, Exp 06/14
RECALLING FIRM/MANUFACTURER
B. Braun Medical Inc., Irvine, CA, by letter on March 7, 2012. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient Drug): Some batches failed testing for AntiFactor IIa assay for potency and other batches have experienced a drop in potency.
VOLUME OF PRODUCT IN COMMERCE
708,584 Excel Containers
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Morphine Sulfate ER Tablets, 200 mg, Rx only, bottles of 100 count, For use in opioid-tolerant patients only, NDC 0378-2662-01, Recall # D-1283-2012
CODE
Lot 2002900 Exp September 2013 Lot 2002901 Exp September 2013 Lot 3035357 Exp January 2014
RECALLING FIRM/MANUFACTURER
Mylan Pharmaceuticals Inc., Morgantown, WV, by letter on March 9, 2012. Firm initiated recall is ongoing.
REASON
Label: Presence of Undeclared Color Additive; Product outsert indicated Yellow Dye #6, correct nomenclature is Yellow Dye #5.
VOLUME OF PRODUCT IN COMMERCE
2473 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pedia Care Infants Gas Relief Drops (Simethicone), a) Dye-Free/Non-staining Formula, 1fl oz (30ml) UPC Code: 814832011246; b) AntiGas, 1 fl oz (30ml), UPC Code: 814832011253. Recall # D-1284-2012
CODE
Lot # Exp Date: a) 520-1829 08/2012; 520-2047 10/2012; 520-2488 02/2013; 520-2513 02/2013; 520-2515 02/2013; 520-2660 03/2013; b) 521-1849 08/2012; 521-2048 10/2012; 521-2512 02/2013; 521-2517 04/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtech Products, Inc., Irvington, NY, by letters on March 19, 2012.
Manufacturer: Guardian Drug Co., Dayton, NJ. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Nonsterile Products: possible contamination with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
302,400 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Infants' Tylenol (acetaminophen) Oral Suspension, 160 mg per 5 ml, 1 fl oz. (30 ml) bottle packaged with SimpleMeasure(TM) dosing system, Grape flavor; NDC 50580-191-01; UPC 3 0045-0122-30 8. Recall # D-1285-2012
CODE
Lot #: BIL0U00, BIL0V00, BIL3500, Exp 08/13; BJL2D00, BJL2E00, BJL2T00, BJL2U00, Exp 09/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letter on February 17, 2012. 
Manufacturer: Janssen - Cilag S.p.A., Borgo San Michele, Italy. Firm initiated recall is ongoing.
REASON
Defective Container: Recall Due to Dosing System Complaints.
VOLUME OF PRODUCT IN COMMERCE
573,984 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IV Busulfex (busulfan) Injection, 10 mL (6 mg/mL), Single Use Vial, Sterile, Rx Only, For Intravenous Infusion Only, NDC 59148-070-90. Recall # D-1292-2012
CODE
Lot #: 1797784D, Exp 01/2012; 1852754D, Exp 02/2012; 1921438D, Exp 04/2012, 2006877D, Exp 05/2012; 2014420D, Exp 06/2012; 2025212D, Exp 08/2012; 2045802D 11/2012; 2055597D, Exp 03/2013
RECALLING FIRM/MANUFACTURER
Otsuka Pharmaceutical, Princeton, NJ, by letters dated December 22, 2011. Firm initiated recall is ongoing.
REASON
cGMP Deviations
VOLUME OF PRODUCT IN COMMERCE
41,240 Vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Temodar (temozolomide capsules), 5 mg per capsule, 5-count bottle, Rx Only, Cytotoxic, NDC 0085-3002-02. Recall # D-1293-2012
CODE
Unit: 0HLO008
RECALLING FIRM/MANUFACTURER
Schering-Plough Products, LLC, Las Piedras, PR, by letter on February 27, 2012. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: This recall is due to an out of specification result relating to total degradation products detected during stability testing.
VOLUME OF PRODUCT IN COMMERCE
15,970 bottles
DISTRIBUTION
Nationwide and Puerto Rico, Bahamas, Barbados
___________________________________
PRODUCT
Cyclosporine Oral Solution, USP (modified), 100 mg/mL, Rx Only, NDC 60505-0354-1. Recall # D-1294-2012
CODE
Lot #: JN1053, Exp 06/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Inc., Toronto, Canada, by letter dated February 3, 2012.
Manufacturer:Apotex Inc., Richmond Hill, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Presence of Precipitate; The product may contain a light sediment.
VOLUME OF PRODUCT IN COMMERCE
2,019 bottles
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Ropinirole Hydrochloride Tablets, 0.25 mg, 500-count bottle, Rx Only, NDC # 60429-793-05, Recall # D-1286-2012;
 
2) Ropinirole Hydrochloride Tablets, 0.5 mg, a) 30-count bottle, NDC 60429-794-30, b) 90-count bottle, NDC 60429-794-90, and c) 500-count bottle, NDC 60429-794-05, Rx Only. Recall # D-1287-2012;
 
3) Ropinirole Hydrochloride Tablets, 1mg, 500-count bottle, Rx Only, NDC # 60429-795-05. Recall # D-1288-2012;
 
4) Ropinirole Hydrochloride Tablets, 2 mg, 500-count bottle, Rx Only, NDC # 60429-796-05. Recall # D-1289-2012
CODE
1) Lot #s: 102795A, Exp 05/11; 103611A, 103611B, 103612A, 103612B, Exp 07/11; 104441A, Exp 10/11; 104876A, Exp 01/12; 105558A, Exp 03/12;
 
2) Lot #s: a) 105202A, Exp 07/12; b) 105202B, Exp 07/12; c) 103537A, Exp 01/12; 103989A, 103989B, Exp 03/12; 105027A, 105027B, Exp 06/12; 105559A, 105559B, Exp 09/12;
 
3) Lot #s: 102961A, 102962A, 102962B, Exp 12/11; 103668A, 103668B, 104442A, Exp 04/12; 104878A, 104879A, Exp 07/12; 105514A, Exp 09/12;
 
4) Lot #s: 103613A, 103613B, 103613C, 103613D, Exp 01/12; 104067A, 104067B, Exp 04/12; 104623A, Exp 05/12; 1055181A, Exp 09/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden State Medical Supply Inc., Camarillo, CA, by letters on April 28, 2011 and May 3, 2011.
Manufacturer: Corepharma LLC, Middlesex, NJ. Firm initiated recall is complete.
REASON
Impurities/Degradation Products: The firm initiated this voluntary recall to the retail level due to the potential that the affected lots may not meet the specification for a known impurity over the product shelf life.
VOLUME OF PRODUCT IN COMMERCE
3,628 Bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0922-12
CODE
Unit: 01LC60630
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, West Henrietta, NY, by facsimile on June 14, 2005.
Manufacturer: The American National Red Cross, Depew, NY. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0924-12
CODE
Units: 391071423, 391070952, 391070398, 391069891, 391068761, 391068256, 391067679, 391067234, 391066566, 391066055, 391065522, 391065073, 391063959, 391063468, 391062895, 391062487, 391061985, 391061450, 391058835, 391058585, 391058024, 391057723, 391057129, 391056957, 391055843, 391055550, 391055010, 391054760, 391054229, 391053912, 391051754, 391049430, 391048919, 391048080, 391048045, 391047267, 391047086, 391046421, 391046205, 391045349, 391044803, 391044350, 391042620, 391042226, 391041724, 391041263, 391040777, 391040373, 391039855, 391039265, 391038404, 391038062, 391035821, 391034949, 391034042, 391033320, 391032844, 391030916, 391029428, 391025760, 391024941, 391024287, 391023824, 391023297, 391022855, 391022236, 391020845, 391020346, 391019774
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by facsimile on September 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a deferred donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0927-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0928-12;
3) Recovered Plasma. Recall # B-0929-12;
4) Platelets Pheresis Leukocytes Reduced. Recall # B-0930-12;
5) Red Blood Cells Leukocytes Reduced Irradiated. Recall #B-0931-12
CODE
1) Units: 06FC27032, 06FC28191, 06FC31822, 06FC40529, 06FC42779, 06LK82623;
2) Units: 06KC81108 (2 units);
3) Units: 06FC27032, 06FC28191, 06FC31822, 06FC40529, 06FC41637, 06FC42779, 06LK82623;
4) Units: 06KC81391 (2 units), 06KC81605, 06KC81979, 06KC82182;
5) Unit: 06FC41637
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone, facsimile, or electronic notification on September 16, 2008 and by letter dated September 17, 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
21 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0932-12
CODE
Units: 021LC76003, 021LC76041, 021LH39901, 021LK25980, 021LK25982, 021LK25988, 021LK25990, 021LK25992, 021LK25994, 021LK25995, 021LK25999, 021LK26041, 021LK26046, 021LK26054, 021LV19238, 021LV19245, 21LV19253, 021LV19256, 021LV19257, 021LV19261
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on October 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0934-12
CODE
Unit: 4737241
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone on January 31, 2007.
Manufacturer: Florida Blood Services, Inc., Pensacola, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0935-12
CODE
Unit: 102973438
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 30, 2005.
Manufacturer: Black Canyon Center, Phoenix, AZ. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0936-12
CODE
Unit: 4091538
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone on March 16, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0937-12
CODE
Units: 5213979, 5215397
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone on August 28, 2007. 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
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0938-12
CODE
Units: 101978883 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated September 30, 2005. 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
AZ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0939-12
CODE
Unit: 4625149
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone on March 30, 2005.
Manufacturer: Florida Blood Services, Inc., Pensacola, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0940-12
CODE
Unit: 4736845
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone on April 3, 2007. 
Manufacturer: Florida Blood Services, Inc., Pensacola, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0942-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0943-12
CODE
1) and 2) Unit: 06GT49070
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter on August 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0944-12
CODE
Unit: 2921317
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on April 5, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0947-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0948-12
CODE
1) Units: G33581; N17446;
2) Units: N21701; N18192
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and letter on March 5, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0952-12
CODE
Units: 7225770 (BAG1); 7225770 (BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone on June 21, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0955-12;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0956-12;
3) Fresh Frozen Plasma. Recall # B-0957-12
CODE
1) and 3) Unit: 5795427;
2) Unit: 5801910;
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letters and e-mail on October 3, 2008. 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
3 units
DISTRIBUTION
FL, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0960-12
CODE
Units: 0011115783, 0011113953, 0011113062, 0011112720, 0011112170, 0011111736, 0011111210, 0011110806, 0011110290, 0011109880, 0011109377, 0011108980, 0011108527, 0011108069, 0011107557, 0011107083, 0011106547, 0011106165, 0011105610, 0011105256, 0011104752, 0011104373 and 0011103792
RECALLING FIRM/MANUFACTURER
Biotest Pharmaceuticals Corp., Fort Myers, FL, by fax on April 7, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam had not been performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0961-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0962-12
CODE
1) Unit: 9928378;
2) Unit: 6324999
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone and letter on August 20 and 21, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria and leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0964-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0965-12
CODE
1) Unit: 8878259;
2) Units: 9681542-1; 9681542-2
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated July 28, 2008. 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
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-0966-12
CODE
Unit: 9660282
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by fax on July 11, 2008 and letter dated July 18, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-0967-12
CODE
Unit: 9917587 part 1, 9917587 part 2
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by fax on October 6, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet QC specifications for platelet pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0969-12
CODE
Unit: 9926263 part 2, 9926263 part 3
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by fax on October 6, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet QC specifications for platelet pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0978-12
CODE
Units: 2925318; 2910019; 2882459
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter dated April 17, 2006.  
Manufacturer: Downtown Center, San Francisco, CA. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0981-12
CODE
Unit: 4892559
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and follow-up by letter on October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0982-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0983-12
CODE
1) Unit: 7604229 (BAG2);
2) Unit: 7604229 (BAG1)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by facsimile on April 23, 2008.  
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units (split)
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0984-12
CODE
Units: 7602506 (BAG1);7602506 (BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by letter on March 17, 2008.  
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which was possibly contaminated with Propionibacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0921-12
CODE
Unit: 107243838
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 17, 2005.
Manufacturer: Paradise Valley Center, Phoenix, AZ. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0941-12
CODE
Units: 2928637 Part A; 2928637 Part B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and follow-up letter dated March 14, 2006.
Manufacturer: Peninsula Center, Millbrae, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom there was no documentation on the donor record of an arm inspection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0945-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0946-12
CODE
1) and 2) Unit: 2936865
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using expired blood collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0970-12
CODE
Unit: 21LJ33830
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by letter dated July 27, 2006. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0971-12
CODE
Unit: 21KS55935
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by letter dated June 26, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire amount of Adsol added during red cell component preparation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0979-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0980-12
CODE
1) Units: 6060090, 6060097, 6067826, 6067827, 6067831, 6067833;
 
2) Units: 6060091, 6060092, 6060096, 6067829, 6067832, 6067840, 6067841, 6067846, 6068602, 6068609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on April 13, 2006 and by facsimile on April 19, 2006.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. Product Usage: The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to Cardiac Transplanation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief, a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft. Sealed Outflow Graft: Catalog number 103393; Sealed Outflow Short Bend Relief: Catalog number 104692; HM II LVAS Implant Kit (with sealed grafts) [US labeling] (contains catalog number 103393); HM II LVAS Implant Kit (with sealed grafts) [CE Mark labeling], contains catalog no. 103393). Recall # Z-1228-2012
CODE
All lot and serial numbers.
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, by letter on February 23, 2012. Firm initiated recall is ongoing.
REASON
A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified.
VOLUME OF PRODUCT IN COMMERCE
3,852 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Model #: 728269. Recall # Z-1219-2012
CODE
Serial #s: 79901, 79902, 79903, 79904, 79905, 79906, 79907, 79910, 79911, 79912, 79913, 79914, 79916, 79917, 79918, 79920, 79921, 79922, 79923, 79924, 79925, 79926, 79927, 79928, 79929, 79930, 79931, 79932, 79934, 79935, 79936, 79937, 79939, 79940, 79942, 79943, 79944, 79945, 80002, 80005, 80006, 80007, 80009, 80010, 80011, 80025, 80026, 80027, 80031, 80032, 80037, 80039, 80040, 80041, 80042, 80047, 80053, 80054, 80056, 80058, 80059, 80060, 80061, 80062, 80063, 80065, 80066, 80067, 80068, 80069, 80070, 80071, 80072, 80073, 80075, 80076, 80077, 80078, 80079, 80080, 80081, 80082, 80084, 80085, 80086, 80087, 80088, 80091, 80093, 80094, 80095, 80096, 80097, 80098, 80109, 80110, 80111, 80112, 80113, 80114, 80115, 80116, 80117, 80119, 80121, 80123, 80128, 80129, 80130, 80133, 80134, 80137, 80139, 80140, 80141, 80143, 80145, 80146, 80147, 80148, 80149, 80150, 80151, 80152, 80153, 80154, 80155, 80156, 80157, 80158, 80160, 80161, 80162, 80163, 80164, 80165, 80166, 80167, 80168, 80169, 80170, 80171, 80172, 80173, 80174, 80175, 80176, 80177, 80178, 80179, 80180, 80181, 80182, 80183, 80186, 80189, 80190, 80191, 80192, 80193, 80194, 80195, 80198, 80199, 80200, 80201, 80202, 80203, 80204, 80205, 80206, 80207, 80208, 80209, 80210, 80211, 80212, 80213, 80214, 80215, 80216, 80217, 80218, 80219, 80223, 80224, 80226, 80227, 80228, 80229, 80230, 80231, 80232, 80233, 80234, 80237, 80238, 80239, 80240, 80242, 80243, 80244, 80245, 80246, 80247, 80248, 80249, 80250, 80251, 80252, 80253, 80254, 80255, 80256, 80257, 80258, 80259, 80260, 80261, 80262, 80263, 80264, 80265, 80266, 80268, 80269, 80270, 80271, 80272, 80273, 80274, 80275, 80276, 80277, 80278, 80279, 80280, 80281, 80282, 80283, 80284, 80285, 80286, 80287, 80288, 80289, 80290, 80291, 80292, 80293, 80294, 80295, 80296, 80297, 80298, 80299, 80300, 80301, 80302, 80303, 80305, 80306, 80308, 80309, 80312, 80313, 80314, 80315, 80316, 80317, 80318, 80320, 80322, 80323, 80324, 80325, 80326, 80327, 80328, 80329, 80330, 80331, 80332, 80333, 80334, 80335, 80336, 80337, 80339, 80340, 80341, 80344, 80345, 80346, 80347, 80348, 80349, 80350, 80353, 80354, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80377, 80378, 80379, 80380, 80381, 80382, 80383, 80384, 80385, 80386, 80387, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80396, 80397, 80398, 80399, 80401, 80402, 80406, 80409, 80410, 80416, 80417, 80418, 80419, 80420, 80421, 80422, 80423, 80424, 80425, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80435, 80436, 80437, 80438, 80439, 80440, 80442, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 80459, 80460, 80461, 80462, 80463, 80464, 80466, 80467, 80470, 80471, 80472, 80473, 80474, 80475, 80476, 80477, 80479, 80480, 80481, 80482, 80483, 80484, 80485, 80486, 80487, 80488, 80489, 80491, 80492, 80493, 80494, 80495, 80496, 80497, 80502, 80503, 80504, 80505, 80506, 80507, 80508, 80509, 80510, 80514, 80515, 80516, 80517, 80518, 80519, 80520, 80521, 80526, 80527, 80529, 80536, 80537, 80538, 80539, 80540, 80541, 80542, 80543, 80544, 80546, 80547, 80548, 80551, 80552, 80553, 80554, 80555, 80556, 80557, 80558, 80559, 80560, 80561, 80562, 80566, 80567, 80568, 80569, 80570, 80571, 80572, 80573, 80574, 80575, 80576, 80577, 80578, 80579, 80580, 80581, 80582, 80583, 80584, 80585, 80586, 80587, 80588, 80589, 80591, 80592, 80593, 80594, 80595, 80596, 80597, 80598, 80599, 80600, 80601, 80602, 80603, 80604, 80605, 80608, 80609, 80610, 80611, 80612, 80613, 80614, 80615, 80616, 80617, 80618, 80619, 80620, 80621, 80622, 80623, 80624, 80625, 80626, 80628, 80629, 80630, 80632, 80633, 80634, 80635, 80636, 80638, 80639, 80640, 80641, 80642, 80643, 80644, 80645, 80646, 80648, 80649, 80653, 80654, 80657, 80658, 80660, 80661, 80662, 80663, 80664, 80665, 80666, 80667, 80672, 80673, 80674, 80675, 80676, 80677, 80679, 80680, 80681, 80682, 80683, 80685, 80686, 80689, 80690, 80696, 80699, 80700, 80703, 80704, 80706, 80707, 80708, 80709, 80710, 80711, 80712, 80714, 80715, 80719, 80720, 80721, 80722, 80724, 80725, 80726, 80728, 80729, 80730, 80731, 80732, 80733, 80734, 80735, 80736, 80739, 80740, 80741, 80742, 80743, 80744, 80745, 80747, 80748, 80749, 80750, 80751, 80752, 80753, 80754, 80755, 80756, 80757, 80758, 80759, 80760, 80762, 80763, 80764, 80765, 80766, 80770, 80771, 80779, 80781, 80782, 80789, 80793, 80794, 80795, 80796, 80807, 80808, 80810, 80816, 80831, 80833, 80834, 80835, 80836, 80837, 80848, 80849, 80850, 80851, 80860, 80862, 80863, 80864, 80865, 80866, 80867, 80868, 80869, 80870, 80872, 80873, 80874, 80875, 80876, 80878, 80879, 80882, 80883, 80884, 80885, 80886, 80887, 80889, 80891, 80892, 80893, 80898, 80899, 80900, 80901, 80902, 80903, 80905, 80906, 80908, 80909, 80910, 80911, 80913, 80914, 80915, 80916, 80923, 80924, 80925, 80926, 80927, 80929, 80930, 80931, 80936, 80937, 80938, 80939, 80940, 80941, 80942, 80943, 80944, 80945, 80946, 80963, 80964, 80965, 80966, 80967, 80968, 80969, 80971, 80973, 80974, 80975, 80977, 80979, 80980, 80981, 80982, 80985, 80987, 80988, 80989, 80992, 80993, 80995, 80998, 80999, 81001, 81002, 81005, 81007, 81008, 81009, 81023, 81025, 81026, 81029, 81030, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81039, 81042, 81043, 81045, 81046, 81047, 81048, 81050, 81059, 81061, 81062, 81063, 81064, 81065, 81066, 81067, 81068, 81069, 81070, 81071, 81076, 81077, 81079, 81081, 81082, 81084, 81086, 81087, 81088, 81089, 81090, 81097, 81098, 81099, 81100, 81101, 81107, 81108, 81109, 81111, 81117, 81118, 81119, 81124, 81125, 81126, 81127, 81128, 81129, 81130, 81132, 81133, 81134, 81135, 81136, 81147, 81148, 81149, 81150, 81154, 81156, 81157, 81159, 81160, 81161, 81162, 81163, 81164, 81165, 85001, 85004
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 08, 2012. Firm initiated recall is ongoing.  
REASON
Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.
VOLUME OF PRODUCT IN COMMERCE
822 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. Recall # Z-1227-2012
CODE
Lot Number: N1H0037LX
RECALLING FIRM/MANUFACTURER
Covidien LP, North Haven, CT, by letter dated February 16, 2012. Firm initiated recall is ongoing.
REASON
Missing component results in the stapler not firing.
VOLUME OF PRODUCT IN COMMERCE
1,158 units
DISTRIBUTION
Nationwide and Venezuela
___________________________________
PRODUCT
CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. Catalog # FG-5400-00. Recall # Z-1230-2012
CODE
Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letter on February 9, 2012.
Manufacturer: Biosense Webster Israel Ltd., Yokneam, Israel. Firm initiated recall is ongoing.
REASON
Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.
VOLUME OF PRODUCT IN COMMERCE
134 units total (32 units US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Suture removal kit, catalog# 900-010. Recall # Z-1251-2012;
 
2) Irrigation Tray w/Bulb syringe, catalog# 900-020. Recall # Z-1252-2012;
 
3) Prep shave kit, catalog# 900-030. Recall # Z-1253-2012;
 
4) Universal drainage kit, catalog# 900-032. Recall # Z-1254-2012;
 
5) Tracheotomy care kit, catalog# 900-110. Recall # Z-1255-2012;
 
6) Suction Catheter Kit, catalog# 900-277. Recall # Z-1256-2012;
 
7) Urethral Catheter Tray catalog# 900-278. Recall # Z-1257-2012;
 
8) Incision and Drainage Tray, catalog# 900-774. Recall # Z-1258-2012;
 
9) Skin Stapler Removal Kit, catalog# 900-782. Recall # Z-1259-2012;
 
10) Minor laceration tray, catalog# 900-1765. Recall # Z-1260-2012;
 
11) Wound Closure Tray I, catalog# 900-063. Recall # Z-1261-2012;
 
12) Wound Closure Tray II, catalog# 900-064. Recall # Z-1262-2012;
 
13) Wound Management Tray, catalog# 900-540. Recall # Z-1263-2012
 
14) Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154. Recall # Z-1264-2012;
 
15) Wound Management Tray, catalog# 900-1456. Recall # Z-1265-2012;
 
16) Wound Management Ryder, catalog# 900-1605. Recall # Z-1266-2012;
 
17) Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903. Recall # Z-1267-2012
CODE
1) Lot numbers: 111010002, 111020256, 111020327, 111030530, 111030751, 111041132, 111061651, 111071868, and 111082283;
 
2) Lot numbers: 111010005, 111030737, 111030813, 111040954, 111051356, 111061630, 111071948, and 111092564;
 
3) Lot numbers: 111020501, 111030532, 111041003, 111051357, and 111071872;
 
4) Lot numbers: 111051312, 111071873;
 
5) Lot numbers: 111010019, 111020470, 111020471, 111030544, 111030820, 111040870, 111041134, 111051144, 111061701, 111071950, and 111082043;
 
6) Lot numbers: 1111051040, 111051330, 111061664, 111071936, 111082213, and 111102737;
 
7) Lot numbers: 111010111, 111010236, 111020479, 111051042, 111051381, 111061595, 111071961, and 111092601;
 
8) Lot numbers: 111030722, 111061688;
 
9) Lot numbers: 111010162, 111020297, 111020447, 111030661, 111051350, 111061689, 111071836, 111082228, and 111102887;
 
10) Lot numbers: 111010245, 111020332, 111020333, 111020506, 111030616, 111040994, 111051168, 111061621, 111071912, 111082098, and 111092569;
 
11) Lot numbers: 111010011, 110122973, 111020329, 111020330, 111030537, 111041095, 111051223, 111051457, 111071876, and 111082178;
 
12) Lot numbers: 111010192, 111030720, 111051229, and 111092179;
 
13) Lot numbers: 111030688, 111071824;
 
14) Lot numbers: 111010025, 111020497, 111030548, 111041068, 111061631, and 11102825;
 
15) Lot numbers: 111051053, 111051316, 111061635, 111082187, and 111092568;
 
16) Lot numbers: 111051036, 111051318, 111071901, 1110082194, and 111092356;
 
17) Lot numbers: 111051062, 111092570
RECALLING FIRM/MANUFACTURER
Customed, Inc., Fajardo, PR, by letter dated December 8, 2011. Firm initiated recall is ongoing.
REASON
Packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
VOLUME OF PRODUCT IN COMMERCE
200,927 units of various products
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Recall # Z-1270-2012
CODE
MOSIAQ System model number 10568605.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters on April 14, 2012.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.
REASON
Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A
VOLUME OF PRODUCT IN COMMERCE
44 active devices
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally
___________________________________
PRODUCT
CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures. Recall # Z-1275-2012
CODE
Multiple codes
RECALLING FIRM/MANUFACTURER
Healthtronics, Inc., Austin, TX, by letter dated February 27, 2012. Firm initiated recall is ongoing.
REASON
There have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.
VOLUME OF PRODUCT IN COMMERCE
9,274 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address the most common arthritic disorders affecting the shoulder. The spherical reamer is used to prepare the glenoid fossa and provide a uniform surface for instrumentation and implant placement. The glenoid fossa is then sized using surface templates to confirm the appropriate coverage, size and curvature has been determined. To achieve this in surgery, the spherical reamer (5900-2050/-2051/-2052/-2053) must be attached to the Angled Glenoid Driver (5900-2040) by threading the reamer's male threads into the driver's female threads. The spherical reamers come in sizes 5, 7, 9 & 11, each with a captive drill head screw (5900-2054/-2055). The spanner features two kidney shaped male lobes that mate with two similar kidney shaped female slots in the screw's head and is used to tighten and loosen the spherical reamers with the angled driver. These instruments are part of the Solar Total Shoulder Instrument set and can be found in Surgical Protocol LSPUE-4 dated 10/04. Each set contains one spanner that universally fits all size reamers. Glenoid Reamer Spanner Catalog Number: 5900-2056, 510k Exempt. Recall # Z-1276-2012
CODE
Lot Code: F3W7017
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated December 21, 2011. Firm initiated recall is ongoing.
REASON
Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Product Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin. Recall # Z-1280-2012;
 
2) VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Product Usage: CTS Usage: Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin. Recall # Z-1281-2012
CODE
1) All codes distributed between 05/02/2006 08/31/2011;
2) All codes distributed between 02/11/2008 03/31/2011
RECALLING FIRM/MANUFACTURER
Christie Medical Holding Inc., Memphis, TN, by letter on March 14, 2012. Firm initiated recall is ongoing.
REASON
Instrument may tip over if not moved correctly.
VOLUME OF PRODUCT IN COMMERCE
1,050 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes, 10 tubes/package. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Recall # Z-1282-2012
CODE
Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Diagnostic Systems, Sparks, MD, by letter dated February 2012. Firm initiated recall is ongoing.    
REASON
In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
VOLUME OF PRODUCT IN COMMERCE
6,930 tubes
DISTRIBUTION
Nationwide, and Belgium, Canada, China, Japan, Mexico, and Taiwan
___________________________________
PRODUCT
Product is labeled in part: "***REF: 01-7036, Lot 999999, "1.5MM" System Plate L-Shape, 3 X 3 Hole, 100 Degree, Qty 00001, CE 0086, 2010-04 *** NON-STERILE Product ***, Left, X-Long, 0.6 MM Titanium, 01-736, Lot 999999, Qty 00001, L-Shape, 3 X 3 Hole, 100 Degree, Left, X-Long, 0.6 MM, CE 0086.***" Product Usage - CTS Usage: Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-1286-2012
CODE
Lot number: 193690
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, LLC, Jacksonville, FL, by letter dated April 21, 2010, by E-mail, letter or telephone the week of April 26, 2010. Firm initiated recall is ongoing.
REASON
Product is labeled incorrectly.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" (31 em) long. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5779. Recall # Z-1287-2012;
 
2) Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog Number: 5767. Recall # Z-1288-2012;
 
3) Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating surface coating. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number 5767X. Recall # Z-1289-2012;
 
4) Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5761. Recall # Z-1290-2012;
 
5) Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating" surface coating. Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5761X. Recall # Z-1291-2012;
 
6) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 8.75" (22cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 144979. Recall # Z-1292-2012;
 
7) Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with 0580178 luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5762. Recall # Z-1293-2012;
 
8) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. long, with Xcoating" surface coating Catalog number: 5762X. Recall # Z-1294-2012;
 
9) Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5768. Recall # Z-1295-2012;
 
10) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5768X. Recall # Z-1296-2012;
 
11) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector, 14" (36cm) long, with Xcoating"surface coating Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5772. Recall # Z-1297-2012;
 
12) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector,12" (31cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5774. Recall # Z-1298-2012;
 
13) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" connector, 12" (31cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 5781. Recall # Z-1299-2012;
 
14) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6384. Recall # Z-1300-2012;
 
15) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6386. Recall # Z-1301-2012;
 
16) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" connector, 12" (31 cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6390. Recall # Z-1302-2012;
 
17) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector, 12" (31cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6391. Recall # Z-1303-2012;
 
18) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6392. Recall # Z-1304-2012;
 
19) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 7.0mm (21 Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6394. Recall # Z-1305-2012;
 
20) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) lonq Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6398. Recall # Z-1306-2012;
 
21) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) OD with 3/8" connector, 12" (31cm) long Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 6399. Recall # Z-1307-2012;
 
22) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 7071. Recall # Z-1308-2012;
 
23) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 7072. Recall # Z-1309-2012;
 
24) Sarns Soft-Flow Aortic Cannula without suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long, with Xcoating" surface coating Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 7072X. Recall # Z-1310-2012;
 
25) Sarns Soft-Flow Aortic Cannula with suture flange Angled tip, wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector, 14" (36cm) long Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 7080. Recall # Z-1311-2012;
 
26) Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 71424-06. Recall # Z-1312-2012;
 
27) Glendale Memorial XCoated Pack Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. Catalog number: 71424-07. Recall # Z-1313-2012;
 
28) Glendale Memorial Fx Pack Product Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures, catalog number: 73300. Recall # Z-1314-2012
CODE
1) Lot numbers: 0545579, 0548150, 0554137,0558396, 0562512, 0569935, 0576823, 0584962, 0589209, 0595115, 0601515, 0606478, 0612440, 0618280, 0622453, 0626218, 0635379, 0639446, and 0646536;
 
2) Lot numbers: 0545582, 0548139, 0548619, 0549398, 0553274, 0555865, 0558398, 0559101, 0564329, 0569936, 0572248, 0577873, 0583200, 0589210, 0592730, 0597079, 0601909, 0607221, 0613013, 0618448, 0621281, 0624903, 0626217, 0630092, 0633295, 0636279, 0641286, 0643913, 0648095, 581714C, and 628998C;
 
3) Lot numbers: 0602378, 0619845, 0633666, and 0641873;
 
4) Lot numbers: 0545183, 0545583, 0548140, 0548618, 0549399, 0553276, 0555220, 0555866, 0556607, 0559102, 0562330, 0567184, 0568703, 0571184, 0576564, 0579082, 0582492, 0587313, 0591057, 0596897, 0601695, 0603419, 0610242, 0614233, 0618452, 0620914, 0622327, 0626216, 0630792, 0633214, 0633296, 0637311, 0640508, 0643258, 0647967, and 628995C;
 
5) Lot numbers: 0561803, 0582268, 0605510, 0621284, 0626220, 0629742, and 0639290;
 
6) Lot numbers: 0626594 and 0642408;
 
7) Lot numbers: 0542768, 0544554, 0545335, 0551287, 0553873, 0561128, 0565375, 0568702, 0570466, 0576324, 0580178, 0583199, 0589212, 0593476,0597085, 0600243, 0605100, 0607906, 0610738, 0614324, 0618450, 0619846, 0621467, 0626108, 0630486, 0632722, 0634951, 0639450, 0643244, and 0646136;
 
8) Lot numbers: 0581640, 0590874, 0626264, 0638886, and 0645179;
 
9) Lot numbers: 0543663, 0545336, 0548173, 0551627, 0554939, 0557537, 0561015, 0562328, 0566132, 0570465, 0575369, 0579077, 0582604, 0589450, 0593473, 0599339,0603200, 0605098, 0609907, 0612593, 0618435, 0619848, 0621468, 0625580, 0630484, 0632631, 0634752, 0637801, 0641064, 0645874, 593736C, and 621484C;
 
10) Lot numbers: 0584829, 0626265, and 0627087;
 
11) Lot numbers: 0545580, 0548151,0 548695, 0555219, 0558397, 0560849, 0567183, 0568622, 0574904, 0581537, 0584771, 0592946, 0593471, 0599195, 0607905, 0613021, 0618232, 0622415, 0628959, 0632822, 0640507, 0643265, and 0646134;
 
12) Lot numbers: 0551682, 0562327, 0567182, 0576283, 0581820, 0595116, 0598462, 0605197, 0620811, 0627377, 0631693, 0634182, and 0643837;
 
13) Lot numbers: 0556606, 0557406, 0561802, 0565374, 0572088, 0581521, 0583114, 0600245, 0605087, 0612281, 0617508, and 0629924;
 
14) Lot numbers: 0544530, 0553053, 0562326, 0575817, 0584770, 0592945, 0599338, 0615127, 0623937, 0625574, 0633313, 0643675, 0648092, and 594444C;
 
15) Lot numbers: 0546837, 0554935, 0562325, 0568617, 0571550, 0581137, 0589932, 0594691, 0603418, 0613014, 0620078, 0626105, 0633133, 0638017, 0641285, 0649120, and 628993C;
 
16) Lot numbers: 0563840;
 
17) Lot numbers: 0542266, 0550479, 0556022, 0562511, 0572245, 0585965, 0594690, 0603594, 0615122, 0622119, 0634179, and 0636399;
 
18) Lot numbers: 0543332, 0546822, 0548676, 0557364, 0562324, 0564328, 0569356, 0575368, 0581608, 0583783, 0588343, 0592028, 0595252, 0601390, 0603880, 0609906, 0613277, 0618231, 0624817, 0626717, 0629741, 0637796, 0642444, 0645174, and 581736C;
 
19) Lot numbers: 0546814, 0551455, 0554919, 0556605, 0559943, 0562323, 0563863, 0565369, 0569977, 0571822, 0578746, 0584741, 0589428, 0590865, 0595113, 0600216, 0605363, 0609905, 0611582, 0618230, 0620597, 0623643, 0631691, 0632823, 0634949, 0638016, 0641049, 0647966, and 621703C;
 
20) Lot numbers: 0546813, 0555863, 0562322, 0569306, 0577787, 0584943, 0599401, 0615034, 0621279, 0632293, and 0643366;
 
21) Lot numbers: 0544529, 0553859, 0557361, 0567784, 0574998, 0580837, 0593876, 0597310, 0605364, 0614872, 0621276, 0627249, 0630091, 0637040, and 0646499;
 
22) Lot numbers: 0546809, 0554132, 0560761, 0565373, 0568214, 0569934, 0573520, 0578158, 0587128, 0592930, 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, 0626796 0627831, 0633293, 0637792, 0641871, 0644451, 0646497, and 0649570;
 
23) Lot numbers: 0544528, 0554918, 0560152, 0569990, 0581059, 0584372, 0590460, 0596909, 0602542, 0614871, 0620810, 0627830, 0632581, 0633132, 0638874, 0643242, and 0648089;
 
24) Lot numbers: 0557561 and 0629806
 
25) Lot numbers: 0546799, 0554917, 0568572, 0582338, 0592942, 0602387, 0607904, 0614870, 0624902, 0627192, 0634105, 0639444, and 0641037;
 
26) Lot numbers: MD15;
 
27) Lot numbers: MD15R, ME12, MG07, ME19, MG21, ML07, MM18R, NA03, and NC28;
 
28) Lot numbers: NF02, NF23, and NK01
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated February 23, 2012. Firm initiated recall is ongoing.
REASON
During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
VOLUME OF PRODUCT IN COMMERCE
188,282 Cannulae and 248 Custom Tubing Packs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided. Recall # Z-1315-2012
CODE
Units: 2009-42-C102636 2009-42-C102637 2009-42-C102638 2009-42-C102639 2009-42-C102640 2009-42-C102641 2009-42-C102642 2009-42-C102643 2009-42-C102644 2009-42-C102645 2009-42-C102646 2009-42-C102647 2009-42-C102648
RECALLING FIRM/MANUFACTURER
QRS Diagnostic, Maple Grove, MN, by letter dated February 9, 2012. Firm initiated recall is ongoing.
REASON
This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretation by the Office Medic Software.
VOLUME OF PRODUCT IN COMMERCE
13 devices
DISTRIBUTION
Nationwide and Belgium, France, Italy, Mali and Senegal
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
___________________________________
PRODUCT
1) Staples Dairy Ration (LL), 1945 LL, Net Wt 50 lb (22.67 KG) or Bulk, UPC 722304234355. Recall # V-061-2012;
 
2) ML09261 Salley Parlor/TMR, (FOR RUMINANTS ONLY), Product Code: 160000 BL, Net Wt. on Bag or Bulk. Recall # V-062-2012
CODE
1) 0815, 0902, 0919, 1003, 1021, 1107, 1118 (code appears behind 1945 LL) "1104" is not a code that is involved in the recall, it was generated as an example of the placement of the date code on the sample label;
 
2) The product is not coded.
RECALLING FIRM/MANUFACTURER
Cargill Inc Animal Nutrition Division, Lecompte, LA, by telephone on December 5, 2011, and by letter on December 21, 2011. Louisiana initiated recall is complete.
REASON
Dairy feed may contain Aflatoxin above the legal limit.
VOLUME OF PRODUCT IN COMMERCE
302,300 lbs
DISTRIBUTION
LA
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS III
___________________________________
PRODUCT
Nutrena (R) NATUREWISE (R) Goat Pellets 16 (MG), 91705 MG, Net Wt on Bag or Bulk. Recall # V-063-2012
CODE
Lot code/datecode: 1MG1365/1MG1DEC31, 3MG2049/3MG2FEB18, 1MG2056/1MG2FEB25
RECALLING FIRM/MANUFACTURER
Cargill Inc., Animal Nutrition Division, Montgomery, AL, by telephone on March 5, 2012 and press release on March 7, 2012, and by telephone and letters on March 8, 2012. Firm initiated recall is ongoing.
REASON
Goat feed contains Decoquinate, an anti-parasitic, which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
1,000 units
DISTRIBUTION
NC, GA, AL, MS and the northern panhandle of FL
 
END OF ENFORCEMENT REPORT FOR APRIL 4, 2012
 
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