Pack, Hot Or Cold, Disposable

HAWK Warming Grid, Item Number: 59-300

Incorrect expiration date.

HAWK Advanced Hypothermia Management Set, Item Number: 59-320

Incorrect expiration date.

Kits of Convenience containing 1 of the 2 Item Numbers:

Incorrect expiration date.

Infant Heel Warmers w/strap, Reference # 989805603201 1223

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.

evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim

eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima

eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

Heel warmers may cause first and second degree burns.