Recall Z-0543-2016 ยท IMD Pack, Hot Or Cold, Disposable
Philips Electronics North America Corporation
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
| Date | Dec 24, 2015 (initiated Nov 20, 2015) |
| Status | Terminated |
| Reason | Heel warmers may cause first and second degree burns. |
| Root cause | Labeling design |
| Action | Cardial Health was notified of the recall via letter on 11/20/2015. Cardinal Health notified all of their customers as of 12/1/2015. Philips instructed Cardinal Health do take the following steps: 1.) Check for and destroy any inventory of Cardinal Health Tiny Toes. 2.) Complete the Distributor Reply Form included in this letter to document this action. Fax to Philips Healthcare at +1 404-855-4900. Please do not return any product to Philips. 3.) Determine which of your customers may have affected product. 4.) Ask your customers to follow the instructions in the section entitled: ACTION |
| Quantity | 7,327,100 individual units |
| Distribution | Moberly, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936084 | OMNI WARM GEL PACKS Omni Therm, Inc., Mar 31, 1994 |