Sorin Group USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
52
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0076-2018Class IIFlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use stSeptember 28, 2017
Z-2771-2017Class IISTOCKERT Heater-Cooler System 3T, 230 VJune 30, 2017
Z-2776-2017Class IISTOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 HzJune 30, 2017
Z-2775-2017Class IISTOCKERT Heater-Cooler System 3T, 120V/60 HzJune 30, 2017
Z-2773-2017Class IISTOCKERT Heater-Cooler System 3T, 208V/60 HzJune 30, 2017
Z-2772-2017Class IISTOCKERT Heater-Cooler System 3T, 240V/60 HzJune 30, 2017
Z-2774-2017Class IISTOCKERT Heater-Cooler System 3T, 127V/60 HzJune 30, 2017
Z-2793-2017Class IISORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2796-2017Class IINON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLIJune 29, 2017
Z-2785-2017Class IISORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2786-2017Class IISORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2794-2017Class IISORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2791-2017Class IISTERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO,June 29, 2017
Z-2798-2017Class IINON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USEJune 29, 2017
Z-2790-2017Class IISORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2795-2017Class IISORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2784-2017Class IISORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx OnlyJune 29, 2017
Z-2789-2017Class IISORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EAJune 29, 2017
Z-2788-2017Class IISORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) June 29, 2017
Z-2783-2017Class IISORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EAJune 29, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K122735SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2May 21, 2013
K102983VASCUCLEAR PRECISION BIPOLARNovember 1, 2010