Recall Z-1186-2016
Sorin Group USA, Inc. · initiated August 15, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1186-2016
- Initiated
- August 15, 2012
- Posted by FDA
- March 17, 2016
- Terminated
- May 26, 2017
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 1125 units
- Distribution
- Worldwide Distribution - US Nationwide, VA/govt/military
- Recalling firm
- Sorin Group USA, Inc., Arvada, CO