Philips North America Llc Recall 89163
Description: Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Philips North America Llc Recall 89163 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0509-2022 |
| Event ID | 89163 |
| Event Description | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 |
| Product Type | Devices |
| Distribution | US Nationwide and Canada. |
| Quantity | 2,925,800 units |
| Recall 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. |
| Device Classification | 20220126 |
| Device Code Info | All units are impacted |
| Center Classification Date | 20220119 |
| Recall Initiation Date | 20211129 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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