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Recall Observatory FDA recall evidence

Device product

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

Z-0508-2022

November 29, 2021

Class II

Product summary

Firm
Philips North America Llc
Event
Event 89163
Status
Ongoing
Classification
Class II
Quantity
4,920,600 units
Official record key
device-enforcement:Z-0508-2022

Official wording

Reason: 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.

Code information: All units are impacted

Distribution pattern: US Nationwide and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.