Z-0509-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- November 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,925,800 units
Product Description
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
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.
Distribution Pattern
US Nationwide and Canada.
Code Information
All units are impacted