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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 18 Results
510(K) Number: K981613
 
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LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing... 3 02/27/2020 LivaNova USA Inc.
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm n... 3 02/21/2018 LivaNova USA
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) ... 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO,... 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA 2 07/29/2017 Sorin Group USA, Inc.
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