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Philips North America Llc recalls Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Recalled January 26, 2022 · FDA recall Z-0509-2022 · 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
2,925,800 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
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →