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U.S. Department of Health and Human Services

Medical Device Recalls
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ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of pat... 3 05/05/2020 FEI # 1415939
Abbott Laboratories
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of pat... 3 05/05/2020 FEI # 1415939
Abbott Laboratories
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patien... 3 05/05/2020 FEI # 1415939
Abbott Laboratories
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 3 04/30/2020 FEI # 1000136573
Ortho Clinical Diagnostics
Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18J... 3 04/15/2020 FEI # 1216677
CooperSurgical, Inc.
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve gu... 3 03/11/2020 FEI # 3003418325
Integra LifeSciences Corp.
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)076300168532... 3 03/04/2020 FEI # 1000220815
Advanced Bionics, LLC
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facil... 3 02/27/2020 FEI # 3013876692
Maquet Cardiovascular Us Sales, Llc
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facil... 3 02/27/2020 FEI # 3013876692
Maquet Cardiovascular Us Sales, Llc
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing... 3 02/27/2020 FEI # 1718850
LivaNova USA Inc.

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