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U.S. Department of Health and Human Services

Medical Device Recalls
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Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ... 1 06/08/2023 BearCare, Inc.
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1... 1 07/22/2022 Baxter Healthcare Corporation
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: ... 1 08/12/2019 Fenwal Inc
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11... 1 07/11/2019 Becton Dickinson & Company
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside... 1 04/07/2016 Vascular Solutions, Inc.
Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) and Squishon 2 91033-2. ... 1 12/16/2014 Philips Medical Systems, Inc.
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % EC... 1 08/29/2014 Customed, Inc
Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and crad... 1 08/20/2014 Childrens Medical Ventures
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ... 1 05/12/2014 Baxter Corporation Englewood
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulat... 1 09/13/2013 B Braun Medical, Inc.
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