FDA-Device2022-01-26Class II
Infant Heel Warmers w/strap, Reference # 989805603201 1223
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
5,164,600 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2022Don't want to check this manually?
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