Product Safety Recalls

Product Recall Tracker

Philips North America Llc Recall 89163

Description: Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

Philips North America Llc Recall 89163 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0508-2022
Event ID89163
Event DescriptionCardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Product TypeDevices
DistributionUS Nationwide and Canada.
Quantity4,920,600 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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.