PlainRecalls
FDA Devices Moderate Class II Terminated

CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection

Reported: March 25, 2015 Initiated: January 26, 2015 #Z-1298-2015

Product Description

CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 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
20398889 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?
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection. Recalled by CooperSurgical, Inc.. Units affected: 20398889 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-1298-2015.