medical Class II Updated 2022-01-26

Philips North America Llc recalls Cardinal Infant Heel Warmer, Reference # 989805617251 11470-

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units are impacted
View official government recall

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