Recall Z-0508-2022— Philips North America Llc

Name: FDA recall Z-0508-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-29

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2021-11-29. It names one FDA 510(k) clearance: K936084. Product: Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T. 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..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-11-29
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K936084 — OMNI WARM GEL PACKSOmni Therm, Inc.·cleared 1994-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.