Product Safety Recalls

Product Recall Tracker

Philips North America Llc Recall 89163

Description: Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

Philips North America Llc Recall 89163 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0509-2022
Event ID89163
Event DescriptionMedichoice Infant Heel Warmer, Reference # 989805643721 1079906
Product TypeDevices
DistributionUS Nationwide and Canada.
Quantity2,925,800 units
Recall ReasonAfter 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.
Device Classification20220126
Device Code InfoAll units are impacted
Center Classification Date20220119
Recall Initiation Date20211129
Recalling FirmPhilips North America Llc
Initial Notification Letter
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