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U.S. Department of Health and Human Services

Medical Device Recalls

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HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M... 1 Mar-24-2017 Philips Electronics North America Corporation
7F Prelude® Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4... 1 Mar-24-2017 Merit Medical Systems, Inc.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/me... 1 Mar-03-2017 Physio-Control, Inc.
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 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Wal... 1 Jan-18-2017 BARD PERIPHERAL VASCULAR, 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
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.
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS m... 1 Jan-13-2017 BioMerieux SA

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