Recall Z-0508-2022 ยท IMD Pack, Hot Or Cold, Disposable
Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
| Date | Jan 19, 2022 (initiated Nov 29, 2021) |
| Status | Open, Classified |
| 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. |
| Root cause | No Marketing Application |
| Action | URGENT Medical Device Recall notification letters dated November 2021 were sent to customers. The actions that should be taken by the customer / user to prevent risks to patients or users 1. Identify all Infant Heel Warmers and Heel Snugglers in your possession. 2. Destroy all Infant Heel Warmers and Heel Snugglers, regardless if they are expired or not. 3. Please complete the Urgent Medical Device Recall Response Form online by using the URL provided on the form. 4. Identify and source an alternative device to meet your needs. Philips will no longer offer the Infant Heel Warmers and Heel Sn |
| Quantity | 4,920,600 units |
| Distribution | US Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936084 | OMNI WARM GEL PACKS Omni Therm, Inc., Mar 31, 1994 |