FDA-Device2022-01-26Class II
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips North America Llc
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
2,925,800 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0509-2022Don't want to check this manually?
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