Recall Z-1186-2016 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Sorin Group USA, Inc.
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
| Date | Mar 17, 2016 (initiated Aug 15, 2012) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Quantity | 1125 units |
| Distribution | Worldwide Distribution - US Nationwide, VA/govt/military |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH, Jun 6, 2006 |