Sorin Group USA, Inc.: 30 recalls on record

Recalls filed with 1 agency: FDA (30).

First recall on record: October 31, 2012. Most recent: August 16, 2017.

Risk classification: Class II: 29 · Class III: 1

Most recent recalls

DateAgencyProduct
August 16, 2017FDASorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage…Z-2871-2017
August 9, 2017FDANON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINI…Z-2798-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx…Z-2793-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EAZ-2794-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx O…Z-2785-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Onl…Z-2789-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 0440426…Z-2788-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx On…Z-2795-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE …Z-2784-2017
August 9, 2017FDASORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EAZ-2786-2017
August 2, 2017FDASTOCKERT Heater-Cooler System 3T, 240V/60 HzZ-2772-2017
August 2, 2017FDASTOCKERT Heater-Cooler System 3T, 208V/60 HzZ-2773-2017
August 2, 2017FDASTOCKERT Heater-Cooler System 3T, 230 VZ-2771-2017
August 2, 2017FDASTOCKERT Heater-Cooler System 3T, 120V/60 HzZ-2775-2017
December 14, 2016FDAPerceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Suture…Z-0716-2017
November 23, 2016FDAThe ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used …Z-0413-2017
July 20, 2016FDAAORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part…Z-2147-2016
March 2, 2016FDACDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack…Z-1018-2016
July 22, 2015FDASorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal p…Z-2080-2015
August 28, 2013FDAEdwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusi…Z-1985-2013
March 20, 2013FDAIsoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead…Z-0928-2013
November 14, 2012FDAS5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is inte…Z-0274-2013
November 14, 2012FDAS5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is int…Z-0272-2013
November 14, 2012FDAS5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is inten…Z-0273-2013
November 14, 2012FDASorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is int…Z-0275-2013

Questions about this company

How many recalls does Sorin Group USA, Inc. have?
Recalert has 30 U.S. recalls on record for Sorin Group USA, Inc., published between October 31, 2012 and August 16, 2017.
What was the most recent Sorin Group USA, Inc. recall?
FDA recall Z-2871-2017, published August 16, 2017: Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary b…
Which agencies have handled Sorin Group USA, Inc. recalls?
Sorin Group USA, Inc. appears as the recalling firm in recalls from: FDA (30).

Do you carry products from Sorin Group USA, Inc.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies