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U.S. Department of Health and Human Services

Medical Device Recalls

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Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead... 1 Jun-05-2017 Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blo... 1 Jun-05-2017 Magellan Diagnostics, Inc.
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaf... 1 Jun-01-2017 Abbott Vascular
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the ... 1 May-26-2017 EBI Patient Care, Inc.
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increa... 1 May-26-2017 EBI Patient Care, Inc.
HeartMate® II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112... 1 May-24-2017 Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240... 1 May-24-2017 Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130240112... 1 May-24-2017 Thoratec Corporation
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. ... 1 May-22-2017 Vascular Solutions, Inc.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 1 May-18-2017 Magellan Diagnostics, Inc.

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