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U.S. Department of Health and Human Services

Enforcement Report - Week of December 23, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Philips Healthcare Brilliance 64 Computed Tomography X-ray system 728231 Class II During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Philips Electronics North America Corporation
Devices Philips Healthcare Ingenuity Core Computed Tomography X-ray system 728321 Class II During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Philips Electronics North America Corporation
Devices Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system 728323 Class II During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Philips Electronics North America Corporation
Devices Philips Healthcare Ingenuity CT Computed Tomography X-ray system 728326 Class II During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan. Philips Electronics North America Corporation
Food Del Pasado Dice Green Chiles 100% Fire Roasted and Peeled NET WT. 6 LB 3 OZ (2.81 kg) packaged in #10 steel cans 491168 Class II Metal Bruce Foods Corporation
Food Sprinkle King, Lime Green Sanding Sugar, 30611201.00N, UPC #30763089281012, NET WT: 150 lb (68.182 kg) 0820585501 Class II Metal Kerry Foods
Food Sprinkle King, White Coarse Sugar, 30621693.L32, UPC: Outer: 30763089281623 / Inner: 763089280601, ,NET WT: 32 lb (14.51 kg). DDA, WHITE CON AA DDA (Coarse White Sugar) , Q31320.L32, 01064873, 01064823 (net wt 8 lb), UPC: Outer: 29519151867 / Inner: 29519151850, NET WT 32 LB (14.51 kg). Sprinkle King, 40#MTO WHITE SUGAR GEMS (Coarse White Sugar), Q32322.440, UPS 1076618323225, NET WT 40 lb (18.14 kg). Sprinkle King, WHITE CON AA SUGAR (Coarse White Sugar), QWHI533.440 , UPS Outer: 10766818323119, NET WT 40 lb (18.14 kg). Bake Sense, WHITE CON AA SUGAR (Coarse White Sugar), 52274, QWHI513.01, UPS Inner: 10018609922743; Outer: 18609522748 , NET WT 32 lb (14.5kg). 0801579902, 0807579903, 0810579902. 0806579909, 0815579901, 0820579904. 0813580105. 0807580103 0807579901 0814579901 Class II Metal Kerry Foods
Food Sprinkle King, Green Sanding Sugar, Q35111.G32,, UPC: 10766818350023, NET WT: 320 lb (144.3 kg). Sprinkle King, Green Sanding Sugar, QGRN413.L32, UPC: 10766818311109/ 00766818311102, , NET WT: 32 lb (14.51kg). Sprinkle King, Green Sanding Sugar, QGRN433.440, UPC: 10766818321122 , NET WT: 40 lb (18.14 kg). 0811585501 0821579911 0819580102 Class II Metal Kerry Foods
Food Sprinkle King, Black Sanding Sugar, QBLK413.L32, UPC: Inner: 00766818310006 ; Outer: 10766818310003, NET WT: 32 lb (14.51 kg). 0821579910 Class II Metal Kerry Foods
Food Sprinkle King, Blue Sanding Sugar, QBLU413.L32, , UPC:Inner: 00766818310303 ; Outer: 10766818310300, NET WT: 32 lb (14.51 kg). 0821579906 Class II Metal Kerry Foods
Food Sprinkle King, Gold Sanding Sugar, QGOL413.L32, UPC:10766818310904/ 00766818310907, NET WT: 32 lb (14.51 kg). 0821579909 Class II Metal Kerry Foods
Food Sprinkle King, Orange Sanding Sugar, QORG413.L32, UPC:766818311706/ 10766818311703, NET WT: 32 lb (14.51 kg). Sprinkle King, Orange Sanding Sugar,QORG413DDA.L32, UPC:766818311706/ 10766818311703, NET WT: 32 lb (14.51 kg). Sprinkle King, Orange Sanding Sugar, QORG513.L32, UPC:766818311737/ 10766818311734, NET WT: 32 lb (14.51 kg). 0813579902, 0824579905. 0821579902 0821579903 Class II Metal Kerry Foods
Food Sprinkle King, Pink Sanding Sugar,QPIN413.L32, UPC:766818312000/ 10766818312007, NET WT: 32 lb (14.51 kg). 0805579903 Class II Metal Kerry Foods
Food Sprinkle King, Red Sanding Sugar,QRED413.L32, UPC:inner 766818312604; outer 10766818312601 , NET WT: 32 lb (14.51 kg). Sprinkle King, Red Sanding Sugar, QRED433.440, UPC: 10766818322655, NET WT: 40 lb (18.14 kg). Sprinkle King, Red Sugar,QRED443.00N, UPC: 10766818342615, NET WT: 150 lb (68.182 kg). 0821579904 0813580107 0806585502 0807585502 Class II Metal Kerry Foods
Food Bake Sense, White Sanding Sugar,m QWHI413.01, 52273, 92273 ( net wt 8 lb), UPC: inner 92273; outer 10018609922736, , NET WT: 32 lb (14.51 kg). Sprinkle King, White Sanding Sugar,QWHI413.L32, UPC:inner 766818313106, outer 10766818313103, NET WT: 32 lb (14.51 kg). 0820579906 0820579905 Class II Metal Kerry Foods
Food Sprinkle King, Yellow Sanding Sugar,QYEL413.L32, UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 32 lb (14.51 kg). 082157990 Class II Metal Kerry Foods
Food Kerry, Cinnamon Topical G4205, SS189, G4205.49, , UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 50 lb (22.68 kg). 0813542301 0813542352 Class II Metal Kerry Foods
Devices Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes. Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107 Model Number: ED-200XT: Serial Number: 8681034 Model Number: ED-250XT: Serial Number: HD077A008 Model Number: ED-310XU: Serial Number: 8591013 Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026 Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022 Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and  ...
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Class II A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing. Fujifilm Medical Systems U.S.A., Inc.
Food HCC Basil Pesto FS and S; Houston Culinary Center Basil Pesto 27906600000 and 27903900000; Sell By Dates 9/26/15 Class III Use of ingredient with violative pesticide residue. H E B
Food HEB Sandwich Tuna Salad 12 Grain 26702200000 Class III Use of ingredient with violative pesticide residue. H E B
Food HCC Greek Pasta Salad Small SS and FS 27901000000 and 27910600000 and 27911800000 Class III Use of ingredient with violative pesticide residue. H E B
Food Ciabatta Albacore Tuna Melt SS 26977600000 Class III Use of ingredient with violative pesticide residue. H E B
Food HEB Shrimp Salad SS and FS By Lb; HEB Shrimp Salad 8 oz 26507900000 and 26900400000 and 26506400000 Class III Use of ingredient with violative pesticide residue. H E B
Food HEB Herb Seared Salmon Herb SS and FS; Houston Culinary Center Herb Seared Salmon 27909300000 and 27920100000; Sell By Dates: 9/25/15, 9/27/15, 9/28/15 Class III Use of ingredient with violative pesticide residue. H E B
Food Asian Salmon with potato and green beans 26526800000 Class III Use of ingredient with violative pesticide residue. H E B
Food HEB Sis Greek Pasta Cuc Feta Kal 4122051984 Class III Use of ingredient with violative pesticide residue. H E B
Food Pizza artichoke chicken 12 in Hot and Cold 23900300000 and 23900200000 Class III Use of ingredient with violative pesticide residue. H E B
Food HEB Herb Seared Salmon, Broccoli, Rice SS 27909800000 Class III Use of ingredient with violative pesticide residue. H E B
Food HCC Salad Tuna Classic Yellowfin SS 27923200000 and 27906800000 Class III Use of ingredient with violative pesticide residue. H E B
Food Yellowfin Tuna Salad Sandwich 23902300000 Class III Use of ingredient with violative pesticide residue. H E B
Food Combo Meal Tuna Salad SS 27900300000 Class III Use of ingredient with violative pesticide residue. H E B
Food Houston Culinary Center Yellowfin Tuna Salad Kit Sell By Dates: 9/20/15, 9/24/15, 9/25/15, 9/27/15 Class III Use of ingredient with violative pesticide residue. H E B
Food Houston Culinary Center Greek Pasta Salad Kit Sell By Dates: 9/19/15, 9/21/15, 9/25/15, 9/26/15 Class III Use of ingredient with violative pesticide residue. H E B
Food Houston Culinary Center Cranberry Turkey Salad Base Sell By Dates: 10/11/15 Class III Use of ingredient with violative pesticide residue. H E B
Food Houston Culinary Center Shrimp Salad Kit Sell By Dates: 10/16/15 Class III Use of ingredient with violative pesticide residue. H E B
Food Houston Culinary Center Penne Mozzarella Salad Kit Sell By Dates: 9/21/15, 9/25/15, 9/26/15 Class III Use of ingredient with violative pesticide residue. H E B
Devices AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity. 160889, 161354 Class II Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing. Summit Medical, Inc.
Devices MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes meltitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes NG1019903H NG1019906H NG1019907H NG1019909H NG1019914H NG1019915H NG1019916H NG1019918H NG1019921H NG1019922H NG1019923H NG1019925H NG1019926H NG1019928H NG1019930H NG1019931H NG1019932H NG1019933H NG1019935H NG1019937H NG1019939H NG1019940H NG1019943H NG1019944H NG1019946H NG1019949H NG1019950H NG1019953H NG1019966H NG1019971H NG1019975H NG1019976H NG1019979H NG1019981H NG1019989H NG1019997H NG1019999H NG1020001H NG1020006H NG1020007H NG1020012H NG1020015H NG1020017H NG1020018H NG1020019H NG1020020H NG1020022H NG1020023H NG1020026H NG1020027H NG1020028H NG1020029H NG1020031H Class II Medtronic MiniMed is recalling the MiniMed 620G insulin pumps because they may experience a malfunction which would result in a pump error message. Medtronic has identified the potential reason for these motor failures as either lack of greasing or deficient greasing in a ball bearing assembly of the motor. Medtronic MiniMed Inc.
Devices MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes meltitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes. NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H NG1016916H NG1017305H NG1019509H NG1019517H NG1019519H NG1019521H NG1019522H NG1019523H NG1019528H NG1019530H NG1019533H NG1019534H NG1019536H NG1019543H NG1019544H NG1019547H NG1019549H NG1019550H NG1019551H NG1019553H NG1019555H NG1019556H NG1019557H NG1019558H NG1019559H NG1019561H NG1019562H NG1019564H NG1019565H NG1019566H NG1019567H NG1019568H NG1019569H NG1019571H NG1019572H NG1019573H NG1019576H NG1019577H NG1019578H NG1019579H  ...
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Class II Medtronic MiniMed is recalling the MiniMed 640G insulin pumps because they may experience a malfunction which would result in a pump error message. Medtronic MiniMed Inc.
Food Heng Cheong Loong Co., Net Wt: 10 oz. (5g), Plastic Bag, Product of U.S.A, UPC 6-930481-211418 N/A Class I Tristar Food Wholesale Co. Inc. is recalling Heng Cheong Loong Co. Golden Raisins because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if they consume this product. Tristar Food Wholesale Co Inc
Food GORGEOUS MEMORY brand Daylily, NET WT: 10.6 oz. (300 g), UPC 6 932960 968806, Product of China --- MINHANG FOOD CO., LTD, 103 Eldridge St., New York City, NY 10002 --- Nutrition Facts: Serving Size: 1 tbsp (100g), Servings Per Container: 4 UPC 6 932960 968806 and no other coding Class I The product contained undeclared sulfites (44779 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets. A & S Food Trading Inc.
Food Curry Chicken Salad, Our Chefs Own, sold by weight UPC Code : 285551 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Curry Chicken Salad Wrap, Made Right Here, sold by weight, 12oz UPC 263144 UPC Code : 285551 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Single Curry Chicken Salad Wrap, Made Right Here, 7oz UPC 263126 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Curry Chicken Salad CC, sold by weight UPC 261068 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food PPK Salad Chicken Curry, sold by weight UPC 263142 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Curry Chicken Salad Rollup, 7oz UPC 265325 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Classic Deli Pasta Salad, Sold by weight UPC 260976 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food FP Pasta Salad Classic Deli, sold by weight UPC 270742 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Classic Deli Pasta Salad, 6oz UPC 0 36406 30001 7 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Food Classic Deli Pasta Salad, 14 oz UPC 0 36406 30264 6 Sell by 10/23/15 Class I Product contaminated with Listeria monocytogenes Whole Foods Market Group Inc.
Biologics Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated W142815035077T; W142815035036A; W1428150253914 (double collection); W142815034392N; W142815029164*; W142815028720S; W142815035245T; W1428150287388; W142815033492V; W142815034081G; W1428150281106; W1428150254482; W142815035165T(double collection); W142815034355X(double collection); W142815034356V; W142815029164*; W142815025343K; W142815034469D (double collection); W142815025558R Class III Apheresis blood products, incorrectly labeled as having an extended expiration date, were distributed. Blood Systems, Inc. dba UBS -Coast
Devices Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes. Lot 1686823, expiry 30 June 2018 Class II Antibiotic concentration may be insufficient which may result in incorrect test results. Remel Inc
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W227715012312 Class II Apheresis product, for which the residual white blood cell count testing did not meet specifications, was distributed. Mid-South Regional Blood Center
Devices OmniPod®, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907 Class I Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. Insulet Corporation
Devices OmniPod®, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. Lot Codes: L41908, L41910, F41935 Class I Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. Insulet Corporation
Biologics Apheresis Platelets, Leukocytes Reduced W036814292571; Class II Blood product, which did not meet the acceptable product specifications, was distributed. OneBlood, Inc.
Biologics Red Blood Cells W050912076666; Class II Blood products, collected from a donor who was previously deferred, were distributed. HCSC-Blood Center
Biologics Red Blood Cells, Leukocytes Reduced W050913013440; W050915039737; Class II Blood products, collected from a donor who was previously deferred, were distributed. HCSC-Blood Center
Biologics Blood and Blood Products for Reprocessing W050912076666; W050913013440; W050915003519; W050915039737; Class II Blood products, collected from a donor who was previously deferred, were distributed. HCSC-Blood Center
Food Metro Irresistibles Gluten Free Cheese Ravioli 6- 9 ounce bags Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609 6 - 9 ounce bags per case; Use By 020317 Class II This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory. Contes Pasta Company, Inc.
Food Metro Brand Irresistibles Gluten Free Cheese Ravioli with Marinara Sauce Microwave Meal 340 g Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609 6 - 340 g (12 ounce) meals per case; Use By 021117 Class II This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory. Contes Pasta Company, Inc.
Food Conte's Gluten Free Wheat Free Cheese Ravioli Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158940092 6 - 12 ounce bags per case; Use By 020317 Class II This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory. Contes Pasta Company, Inc.
Food Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158944458 6 - 12 ounce meals per case; Use By 02052017 and 02112017. Class II This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory. Contes Pasta Company, Inc.
Food Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce (French Labeling - Raviolis Au Fromage avec sauce Marinara) Net Wt. 340 g (12 Ounces) Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734153944458 6 - 12 ounce bags per case; Use By 02112017 Class II This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory. Contes Pasta Company, Inc.
Devices Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. 15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166  ...
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Class II CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. CareFusion 303, Inc.
Food Heartland Flax Meal, Net Wt. 50 lbs. Manufacturing Lot Code: 2T330-04515-101 Class II Specialty Commodities, Inc. is recalling a specific lot of Flax Meal that may be contaminated with Salmonella typhimurium. Specialty Commodities, Inc.
Drugs Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98 Lot #: 24I030, Exp 5/2017 Class III Labeling: Incorrect or Missing Lot AND/OR Exp Date. Teva Pharmaceutical Industries
Biologics Red Blood Cells, Leukocytes Reduced W036514143649; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. LifeShare Blood Centers
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W333615096377; Class II Blood product, with incomplete documentation of the irradiation process, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells, Leukocytes Reduced W036315396351; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Biologics Blood and Blood Products for Reprocessing W036315396351; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. BloodCenter of Wisconsin, Inc
Devices Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M. Class II Particulates: Complaints of rubber coring from the closure of injection vials. Myco Medical Supplies Inc
Biologics Red Blood Cells, Leukocytes Reduced W066515252308; W066515252309; Class III Blood products, leukodepleted greater than three days after collection, were distributed. Blood Bank of Alaska, Inc.
Devices GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures. GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. ****SERIAL NUMBERS OF UNITS IN THE US***************************************** LG151858, LG151859, LG151860, LG151861, LG151862, LG151863, LG151866, LG151868, LG151869, LG151870, LG151872, LG151873, LG151874, LG151875, LG151876, LG151877, LG151878, LG151880, LG151881, LG151882, LG151883, LG151884, LG151885, LG151890, LG151891, LG151892, LG151893, LG151894, LG151895, LG151896, LG151898, LG151899, LG151900, LG151901, LG151903, LG151904, LG151906, LG151907, LG151908, LG151909, LG151917, LG151918, LG151919,  ...
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Class II Verathon has become aware that certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate as a result of insufficient process controls and monitoring, potentially resulting in inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation. Verathon, Inc.
Devices GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital platform. ****SERIAL NUMBERS OF UNITS IN THE US***************************************** AD141605, AD141610, AD141614, AD141615, AD141618, AD141621, AD141622, AD141623, AD141624, AD141646, AD141647, AD141651, AD141652, AD141653, AD141654, AD141655, AD141674, AD141684, AD145000, AD145001, AD145005, AD145006, AD145007, AD145008, AD145010, AD145011, AD145012, AD145013, AD145014, AD145015, AD145027, AD145028, AD145029, AD145030, AD145031, AD145035, AD145036, AD145037, AD145040, AD145041, AD145042, AD145043, AD145044,  ...
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Class II Verathon has become aware that certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate as a result of insufficient process controls and monitoring, potentially resulting in inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation. Verathon, Inc.
Devices MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 414518, Serial number/Software version V3.2 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 415358, Serial number/Software version V3.2 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 416192, Serial number/Software version V3.3 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 416546, Serial number/Software version V4.0 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 417191, Serial number/Software version V4.1 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 419071, Serial number/Software version V4.1 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Devices MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). REF # 419072, Serial number/Software version V4.1 CLI Class II MYLA® software connected to a Laboratory Information System (LIS) and a VITEK® 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID. bioMerieux, Inc.
Food 219772 509998 MARKET DISTRICT APRICOT LOG 219772 509998 MARKET DISTRICT APRICOT LOG Sell by dates 11/7/15 through 11/17/15 (5 day shelf life, started selling 11/2/15 pulled 11/12/2015) Class I All lots of Market District brand Apricot Logs and Poppyseed Logs prepared and sold individually from the Bakery department inside Giant Eagle and Market District supermarkets with sell by dates from November 7, 2015 through November 17, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen Giant Eagle, Inc.
Food 219773 509997 MARKET DISTRICT POPPYSEED LOG 219773 509997 MARKET DISTRICT POPPYSEED LOG Sell by dates 11/7/15 through 11/17/15 (5 day shelf life, started selling 11/2/15 pulled 11/12/2015) Class I All lots of Market District brand Apricot Logs and Poppyseed Logs prepared and sold individually from the Bakery department inside Giant Eagle and Market District supermarkets with sell by dates from November 7, 2015 through November 17, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen Giant Eagle, Inc.
Devices Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. All Lots Class II The flexible shaft of the instruments may break during surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. all lots Class II The flexible shaft of the instruments may break during surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. All Lots Class II The flexible shaft of the instruments may break during surgery. To date there have been 18 reports of breakages during surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient. Aesculap, Inc.
Devices Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and ASHK-0087. Class I There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm. Draeger Medical, Inc.
Food Honey Mustard Pretzel Mix sold under the following brand and size: Girl Scouts, NET WT 7 oz. (198g). No code on packaging but consumers would have received affected product on or before November 15, 2015. Class I The honey mustard pretzel mix lists whey in the ingredient list but does not list Milk in the Contains statement. A. L. Schutzman Company, Inc.
Food Honey Mustard Mix sold under the following brand: Ashdon Farms, Net Wt. 8 oz. (227 g), UPC 79113-41184 No code on packaging but consumers would have received affected product on or before November 15, 2015. Class I The honey mustard mix lists whey in the ingredient list but does not list Milk in the Contains statement. A. L. Schutzman Company, Inc.
Biologics Blood and Blood Products for Reprocessing W200614324618 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross The
Devices Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set). Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate. All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector. Class II Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector. MOOG Medical Devices Group
Devices Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet. Product Usage: Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery. Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715" Class II Bestmed is initiating a field action for Digital Temple Thermometer (DTT) Bestmed is initiating a field action for Digital Temple Thermometer (DTT) due to an incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user. Bestmed, LLC
Devices Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 59963616 60062124 59736951 59682161 59682161 59727259 59727259 59727259 59391951 59391951 59391951 59391951 59391951 59407670 59407670 59407670 59407670 59407670 59407670 59407670 59464977 59464977 59464977 59464977 59464977 59464977 59474664 59474664 59474664 59474664 59481176 59481176 59523673 59523673 59523673 59523673 59523673  ...
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Class II Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices. Edwards Lifesciences, LLC
Biologics Source Plasma 15BWIH0143; 15BWIG9597; 15BWIG2756; 15BWIG0887; 15BWIF5121; 15BWIF3147; 15BWIE8617; 15BWIE5832; 15BWIE4151; 15BWID9083; 15BWID7941; 15BWID4217; 15BWID2947; 15BWIC8276; 15BWIC3754; 15BWIB4549; 15BWIA6392; 15BWIA5075; 15BWIA3677; 15BWIA1986; 15BWIA0310; 14BWIJ8973 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. BioLife Plasma Services L. P.
Food Avocado Leaves (Hoja De Aguacate), Net Wt. 10lbs Lot No. SM100915 Class I Santa Maura Spice & Garlic is recalling avocado leaves (hoja de aguacate) because it may be contaminated with Salmonella. Santa Maura Spice & Garlic Co, Inc.
Devices VentriClear® II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain. Catalog Number: 50318Lot Numbers: F4365351X, F4692818X, NS5274254X, NS5667436X, NS5727900X, NS6079165X, NS6079166X Class II Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling. Cook Inc.
Devices MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery. Versions prior to 2.60. Class II First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking. Elekta, Inc.
Devices Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column Lot Numbers : 02K1300128 and 02L1302324 Class II Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed. Teleflex Medical
Biologics Red Blood Cells, Leukocytes Reduced W036813246768; Class II Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search, were distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W036813246768; Class II Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search, were distributed. OneBlood, Inc.
Devices GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1 00000097546HL6 631654INNOVA 00000097777HL7 937592OPT 00000098434HL4 504568INNOVA41 00000098435HL1 702616RDL31 00000098828HL7 843339INNOVA2 00000098977HL2 202269INNOVA 00000099837HL7 520417OPT3100 00000101009HL9 308865KR31 00000101825HL8 216778LABC 00000112807HL3 517353CATH 00000115275HL0 407CCE323 00000116573HL7 509837SSCL1 00000117808HL6 GON4173729 00000118032HL2 812284IN31 00000118368HL0 318330INNOVA1 00000118712HL9 361788CL323 00000118714HL5 806358INNOVA 00000119286HL3 912384CL 00000119585HL8 GON4263188 00000120996HL4 GON4263188 00000121694HL4 229890CL 00000121719HL9 520GVHCATH 00000124905HL1 217443PUSAM323 00000124965HL5 941483CL1 00000126533HL9 702880CATH1 00000127011HL5 318704CATH2 00000110028HL8 DZ1605VA01 00000108050HL6 082416090051 00000112754HL7 082416230024 00000113435HL2 GON4217188 00000113700HL9 082416010027 00000113963HL3 082416090050 00000113977HL3 082416090047 00000116179HL3 082416090058 00000116903HL6 082416100086 00000117226HL1  ...
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Class II GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems . GE Medical Systems, LLC
Devices GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. 00000116342HL7 BA4020VA03 00000127265HL7 XVV1S15019 00000124734HL5 XV124857HL4 00000121103HL6 HC1251XR03 00000102618HL6 083016020038813 00000128170HL8 083016061894915 00000115935HL9 083016100119314 00000125802HL9 083016200031715 00000123471HL5 083016208011415 00000118232HL8 083016240028414 00000122806HL3 083016247131115 00000112586HL3 083016280008314 00000119769HL8 083016284903114 00000122805HL5 083016287138315 00000114746HL1 083016289336814 00000116996HL0 083016601010614 00000112287HL8 083016801002714 00000108901HL0 083016801024714 00000122417HL9 083016807113615 00000109262HL6 083016807511514 00000123932HL6 083016809698915 00000119571HL8 083016824740714 00000110467HL8 083016846514214 00000104227HL4 083016860037213 00000125616HL3 083016860528415 00000113585HL4 083016861004214 00000128059HL3 083016862769215 00000126960HL4 083016029472715 00000120518HL5 083016866085914 00000120528HL5 GON4260859 00000010594HL3 083016844488913 00000105944HL3 GON4144889 00000129362HL0 0004344218 00000122667HL9 5512XR0010 00000124068HL8 5512XR0032 00000124830HL1 5512XR0033 00000124904HL4 5512XR0025 00000125415HL0 5512XR0034 00000129237HL4 GON4344915 00000115056HL4 PL3480VA01 00000128693HL9 1573XR0032 00000121982HL3 42026VAS01 Class II GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. GE Medical Systems, LLC
Biologics Blood and Blood Products for Reprocessing W0423140164098; W042315003967B; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Systems, Inc
Biologics Red Blood Cells, Leukocytes Reduced W333615042476; Class II Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing W203415242197; Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. American Red Cross Blood Services Northern NewEngland Region
Biologics Source Plasma LR0730962, LR0730963, LR0730964, LR0730965, LR0730967, LR0730968, LR0730969, LR0730970, LR0730971, LR0730972, LR0730973, LR0730974, LR0730975, LR0730983, LR0730984, LR0730987, LR0730988, LR0730995, LR0730996, LR0730997, LR0730998, LR0731001, LR0731002, LR0731003, LR0731005, LR0731006, LR0731007, LR0731008, LR0731009, LR0731010, LR0731011, LR0731012, LR0731013, LR0731016, LR0731017, LR0731018, LR0731019, LR0731020, LR0731022, LR0731023, LR0731024, LR0731025, LR0731026, LR0731027, LR0731047, LR0731048, LR0731049, LR0731051, LR0731053, LR0731054,  ...
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Class III Untested Source plasma for further manufacture was distributed. BPL Plasma, Inc.
Biologics Source Plasma 55, 4290487157, 4290487159, 4290487164, 4290487168, 4290487171, 4290490902, 4290487042, 4290487051, 4290487052, 4290487053, 4290487054, 4290487055, 4290487056, 4290487057, 4290487059, 4290487060, 4290487156, 4290487158, 4290487161, 4290487163, 4290487165, 4290487061, 4290487080, 4290487084, 4290487167, 4290487315, 4290487319, 4290487321, 4290487325, 4290487327, 4290487328, 4290487330, 4290487331, 4290487332, 4290487333, 4290487338, 4290487214, 4290487218, 4290487219, 4290487220, 4290487222, 4290487225, 4290487226, 4290487228, 4290487229, 4290487230, 4290487231, 4290487240, 4290487320,  ...
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Class III Untested Source Plasma for further manufacture was distributed. Octapharma Plasma, Inc.
Biologics Source Plasma 4290481860 Class II Untested Source Plasma for further manufacture was distributed. Octapharma Plasma, Inc.
Devices UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only. all serial numbers Part Nos. 629029, B24465, B24802 Class II Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. Beckman Coulter Inc.
Devices UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only. all serial numbers Part No. 775222 Class II Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. Beckman Coulter Inc.
Devices UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. all serial numbers Part No. B23858 Class II Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. Beckman Coulter Inc.
Devices Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction. Model Number(s): 0910-192-000 Lot Numbers Affected 61406007 expiration date: 8/31/2015 Class II The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date. Stryker Instruments Div. of Stryker Corporation
Biologics Apheresis Platelets, Leukocytes Reduced W071215042535 (triple collection); W071215042353 (triple collection); Class III Apheresis products, for which quality control testing for pH as part of a process validation was not performed, were distributed. Medic Inc
Biologics Plasma Frozen within 24 hours (FP24) W201315267586 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. American National Red Cross Southeastern Michigan Region
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