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Philips North America Llc Recall 89163

Description: Heel Snuggler, Reference # 989805603411 99047

Philips North America Llc Recall 89163 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0507-2022
Event ID89163
Event DescriptionHeel Snuggler, Reference # 989805603411 99047
Product TypeDevices
DistributionUS Nationwide and Canada.
Quantity2,509,100 units (Updated to 2,515,200 as of 2/15/22)
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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