FDA Device recall Z-2364-2019
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-fil…
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-fil… by Coopersurgical, citing 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 ser….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2364-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-08 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
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 intended use of the product is to provide warmth during infant transport within the hospital or between hospitals.
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.
Identifiers
| code_info | IJ780, IJ782, IJ785, IJ789, IJ794, IJ796, IJ804, IJ807, IJ817, IJ824, IJ832, IJ834, IJ841, IJ853, IJ865, IJ874, IJ878,…IJ780, IJ782, IJ785, IJ789, IJ794, IJ796, IJ804, IJ807, IJ817, IJ824, IJ832, IJ834, IJ841, IJ853, IJ865, IJ874, IJ878, IJ884, IJ886, IJ892, IJ895, IJ897, IJ900, IJ902, IJ909, IJ917, IJ920, IJ924, IJ933, IJ946, IJ948, IJ957, IJ962, IJ973, IJ976, IJ982, IJ985, IJ999, IK007, IK009, IK015, IK028, IK038, IK041, IK053, IK060, IK066, IK095, IK102, IK107, IK127, IK135, IK147, IK162, IK164, IK171, IK178, IK184, IK201, IK214, IK238, IK252, IK258, IK265, IK270, IK276, IK298, IK318, IK322, IK330, IK332, IK339, IK353, IK361, IK378, IK384, & IK390 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2364-2019%22
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