PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 25, 2015 Initiated: January 26, 2015 #Z-1300-2015

Product Description

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 for Recall

Products without expiration date have the remote potential for minor burn

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
18696754 units
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by CooperSurgical, Inc.. Units affected: 18696754 units.
Why was this product recalled?
Products without expiration date have the remote potential for minor burn
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1300-2015.