Z-2364-2019Class II

TransWarmer Warming Infant Transport Mattress, Model no. 20421

Name: Z-2364-2019 TransWarmer Warming Infant Transport Mattress, Model no. 20421
Creator: CooperSurgical, Inc.
Published: 2019-07-08
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-07-08 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable... on 2019-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2364-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Posted: 2019-08-24
Terminated: 2020-05-28
Recalling firm: CooperSurgical, Inc.
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.
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: 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 tag: labeling and UDI
FDA 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 CooperSurgical at 203-601-5200 ext. 3300.
Quantity in commerce: 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, & United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2364-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2364-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code IMD

K934631Class ITranswarmerPrism Technologies, Inc. / cleared 1994-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)