🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 8, 2019 CooperSurgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CooperSurgical, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2364-2019

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