STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208
FDA device recall Z-0682-2017 · posted 2016-12-01 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).
- Action taken
- Sorin Group sent an Important Information letter dated August 1, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by then consignee. Consignees were instructed to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU). Consignees with questions were instructed to call 303-467-6527 or 303-467-6503. For questions regarding this recall call 281-228-7260.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DWC
- Quantity affected
- 1,618 units in the US; 129 units outside of US
- Distribution
- Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.
- Date initiated
- 2014-08-01
- Date posted
- 2016-12-01
- Date terminated
- 2017-04-20
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STOCKERT HEATER-COOLER SYSTEM 3T (K052601) | Sorin Group Deutschland GmbH | 2006-06-06 |