FDA-Device2022-01-26Class II
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
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.
Sold states
US Nationwide and Canada.
Affected count
4,920,600 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0508-2022More Philips North America Llc recalls
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