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U.S. Department of Health and Human Services

Medical Device Recalls

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LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy funct... 1 Feb-11-2017 Physio-Control, Inc.
Comprehensive Reverse Shoulder System Humeral Tray Model 115340 1 Feb-11-2017 Zimmer Biomet, Inc.
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Th... 1 Jan-18-2017 BARD PERIPHERAL VASCULAR, INC
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath i... 1 Jan-18-2017 BARD PERIPHERAL VASCULAR, INC
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Wal... 1 Jan-18-2017 BARD PERIPHERAL VASCULAR, INC
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alar... 1 Jan-18-2017 CareFusion 303, Inc.
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS® easyMAG® system is an... 1 Jan-13-2017 BioMerieux SA
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS m... 1 Jan-13-2017 BioMerieux SA
Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill.... 1 Jan-03-2017 Nurse Assist, Inc
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). P... 1 Dec-08-2016 SynCardia Systems Inc.

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