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Philips North America Llc recalls Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Recalled January 26, 2022 · FDA recall Z-0508-2022 · Philips North America
Hazard
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. · FDA Class II
Units
4,920,600 units
Sold at
US Nationwide and Canada.
Description
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.
Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →