Recall record at a glance
| Official record | Z-1186-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Sorin Group USA, Inc. |
| Report date | Mar 23, 2016 |
| Recall initiation date | Aug 15, 2012 |
| Quantity | 1125 units |
| Location | Arvada, CO, United States |
Official product 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
Why the product was recalled
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.
Distribution information
Worldwide Distribution - US Nationwide, VA/govt/military
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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