CooperSurgical recalls TransWarmer Warming Infant Transport Mattress Model 20421 due to risk of skin burns if used with incubators. Some units lack updated safety instructions.
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.
CooperSurgical is recalling their TransWarmer Warming Infant Transport Mattress (Model 20421) because using it with other heat sources like incubators can cause serious skin burns. This recall affects hospitals and caregivers who use the product for infant transport.
The TransWarmer mattress generates heat quickly and can cause skin burns if used alongside other heat-producing devices like incubators. The updated safety instructions (from April 2019) prohibit this combination to prevent serious health consequences.
Hospitals and healthcare providers who use the TransWarmer mattress for infant transport are most at risk. Parents or caregivers using the product outside of medical settings are unlikely to be affected.
Check for the model number 20421 on the product. The recall applies to units sold with older safety instructions that don't include the April 2019 update.
Look for the updated safety instructions from April 2019 that prohibit using the mattress with incubators or other heat sources.
If you have the mattress with older instructions, do not use it with incubators or other heat-producing devices.
CooperSurgical updated safety instructions in April 2019 to clarify that using the TransWarmer mattress with incubators or other heat sources can cause skin burns. Some units do not have this updated instruction.
Check for model number 20421 and look for the updated safety instructions from April 2019. Units without this update are affected.
If you have the product with older instructions, do not use it with incubators or other heat sources. Check the safety instructions for the April 2019 update.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2364-2019 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-2364-2019 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
