Recall Z-0505-2022 ยท IMD Pack, Hot Or Cold, Disposable
Philips North America Llc
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
| Date | Jan 18, 2022 (initiated Nov 26, 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 | An URGENT Medical Device Recall notification letter dated November 2021 was distributed to customers. The actions that should be taken by the customer / user to prevent risks to patients or users: 1. Identify all Infa-Therm Transport Mattress in your possession. 2. Destroy all Infa-Therm Transport Mattress, 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 Infa-Therm Transport Mattress. 5. Share |
| Quantity | 141,744 units (Updated to 141,750 units as of 2/15/22) |
| 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 |