FDA Device recall Z-1300-2015
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable by Coopersurgical, citing products without expiration date have the remote potential for minor burn.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-26 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
Reason
Products without expiration date have the remote potential for minor burn
Identifiers
| code_info | Products without an expiration date and lot number |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2015%22
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