Home / Recalls / Medical Devices
CooperSurgical, Inc. recalls Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : Coope
Recalled July 29, 2015 · FDA recall Z-2147-2015 · CooperSurgical
Hazard
Product marketed without a 510(k) · FDA Class II
Units
6,344,700
Sold at
Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.
Description
Product marketed without a 510(k)
Product
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →