FDA Device recall Z-1186-2016
Stockert Heater-Cooler 3T
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Stockert Heater-Cooler 3T by Sorin Group Usa, citing 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 q….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1186-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-15 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sorin Group Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2016%22
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