Z-0509-2022 Class II Ongoing
FDA device recall Z-0509-2022 was initiated by Philips North America Llc on November 29, 2021 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2,925,800 units.
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