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U.S. Department of Health and Human Services

Medical Device Recalls

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DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366... 1 Jul-22-2016 Carefusion 2200 Inc
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 1 Jul-22-2016 Stryker Sustainability Solutions
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (... 1 Jul-08-2016 HeartWare Inc
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from periphe... 1 Jul-05-2016 Hummingbird Med
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assis... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist ... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or ass... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically con... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanic... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum... 1 Jun-13-2016 Carefusion 211 Inc dba Carefusion

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