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U.S. Department of Health and Human Services

Medical Device Recalls

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PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy 2 Jun-24-2016 Baxter Healthcare Corp.
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB... 2 Jun-23-2016 Ev3, Inc.
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator ... 2 Jun-23-2016 Ceg Enterprises Llc
6534-08N InterActive® Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: I... 2 Jun-23-2016 Implant Direct Sybron Manufacturing, LLC
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fu... 2 Jun-21-2016 Fujifilm Medical Systems U.S.A., Inc.
Myriad handpiece Tissue morcellator 2 Jun-21-2016 Nico Corp.
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are comb... 2 Jun-21-2016 Siemens Medical Solutions USA Inc.
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combin... 2 Jun-21-2016 Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint system... 2 Jun-21-2016 Siemens Medical Solutions USA Inc.
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint sy... 2 Jun-21-2016 Siemens Medical Solutions USA Inc.

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