Z-0508-2022 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
- 4,920,600 units
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.
Distribution Pattern
US Nationwide and Canada.
Code Information
All units are impacted