Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device
FDA device recall Z-1186-2016 · posted 2016-03-17 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWC
- Quantity affected
- 1125 units
- Distribution
- Worldwide Distribution - US Nationwide, VA/govt/military
- Date initiated
- 2012-08-15
- Date posted
- 2016-03-17
- Date terminated
- 2017-05-26
- Location
- Arvada, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOCKERT HEATER-COOLER SYSTEM 3T (K052601) | Sorin Group Deutschland GmbH | 2006-06-06 |