Device 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
Z-1300-2015
Product summary
- Event
- Event 70286
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18696754 units
- Official record key
device-enforcement:Z-1300-2015
Official wording
Reason: Products without expiration date have the remote potential for minor burn
Code information: Products without an expiration date and lot number
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
Derived failure modes
-
Unknown
Products without expiration date have the remote potential for minor burn