Reported Sep 4, 2019 · Terminated
TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- TransWarmer Warming Infant Transport Mattress, Model no. 20421
- Product UsageThe 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
- Lot codes and dates
77 of 77 codes
IJ780IJ782IJ785IJ789IJ794IJ796IJ804IJ807IJ817IJ824IJ832IJ834IJ841IJ853IJ865IJ874IJ878IJ884IJ886IJ892IJ895IJ897IJ900IJ902IJ909IJ917IJ920IJ924IJ933IJ946IJ948IJ957IJ962IJ973IJ976IJ982IJ985IJ999IK007IK009IK015IK028IK038IK041IK053IK060IK066IK095IK102IK107IK127IK135IK147IK162IK164IK171IK178IK184IK201IK214
- Amount recalled
- 49813
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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