—#143928

Product

Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

FDA product code: DWC — Controller, Temperature, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052601
Affected lot / code info: All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;

Why it was recalled

On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.

Root cause (FDA determination)

Device Design

Action the firm took

Sorin Germany, via Sorin Colorado, distributed an important information letter to its US customers on August 15, 2012 informing them about an update of the cleaning and infection procedure for the U.S. market that were included in Revision 12 of the IFU.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide, VA/govt/military

Timeline

Recall initiated: 2012-08-15
Posted by FDA: 2016-03-17
Terminated: 2017-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143928. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.