Recall Z-2364-2019 ยท IMD Pack, Hot Or Cold, Disposable
CooperSurgical, Inc.
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The inten
| Date | Jul 8, 2019 |
| Status | Terminated |
| Reason | The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU. |
| Root cause | Error in labeling |
| Action | On July 8, 2019, the firm began notifying customers of the recall via Urgent Medical Device Correction letters. The letters informed customers that CooperSurgical has updated the IFU to clarify that use of the Transwarmer Mattress with other heat producing devices, such as an incubator, is prohibited. Such use could lead to serious health consequences, such as skin burns. Customers were provided with an updated version of the IFU. Customers were asked to complete and return the acknowledgement and receipt form to the firm. If you have any questions about this recall, please contact CooperSur |
| Quantity | 49813 |
| Distribution | Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934631 | TRANSWARMER Prism Technologies, Inc., Feb 3, 1994 |