FDA Recall
Terminated
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
Recall: Z-1186-2016
·
Initiated August 15, 2012
Recall
- Recall Number
- Z-1186-2016
- Event Number
- 73352
- Firm
- Sorin Group USA, Inc.
- FEI Number
- 1718850
- Product Code
- DWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 15, 2012
- Posted
- March 17, 2016
- Terminated
- May 26, 2017
- Address
- 14401 W 65th Way, Arvada, CO, 80004-3503
Description
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
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.
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.
Distribution
Worldwide Distribution - US Nationwide, VA/govt/military
Quantity
1125 units