Device product
CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
Z-1397-2015
Product summary
- Event
- Event 70368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,807,566
- Official record key
device-enforcement:Z-1397-2015
Official wording
Reason: Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
Code information: Product with no lot/ expiration date on the product label
Distribution pattern: Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES
Derived failure modes
-
Potency or specification failure
may not meet specification