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Sorin Group USA, Inc.

Sorin Group USA, Inc. Recalls

All product recalls associated with Sorin Group USA, Inc..

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Recall Summary

Total Recalls

27

Past Year

0

Class I (Serious)

0

Most Recent

Aug 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 27 recalls

Sorin Group USA, Inc.: ST¿CKERT HeaterCooler System 3T; Item Number 160281, H...

On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).

Class IIModerate

FDAAug 1, 2014Nationwide• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

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FDA

Dec 30, 2009

AZ, CA, FL +9 more

• Sorin Group USA, Inc.

Sorin Group USA, Inc.: , REF: 084500500, Sterile EO, Sorin Group USA, Inc., 1440...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group U...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile E...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin G...

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

FDADec 30, 2009AZ, CA, FL +9 more• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manuf...

Vessel clamping device may break during use.

FDANov 25, 2009Nationwide• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Sorin / Clearglide EVH Low Profile with Scissor, REF KTV1...

Vessel clamping device may break during use.

FDANov 25, 2009Nationwide• Sorin Group USA, Inc.

Sorin Group USA, Inc.: Sorin / Clearglide EVH Small with Scissor, REF KTV17, Ste...

Vessel clamping device may break during use.

FDANov 25, 2009Nationwide• Sorin Group USA, Inc.