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Philips North America Llc recalls Infant Heel Warmers w/strap, Reference # 989805603201 1223
Recalled January 26, 2022 · FDA recall Z-0506-2022 · 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
5,164,600 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
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →