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Recall Observatory FDA recall evidence

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

May 01, 2013

Class II

Product summary

Firm
CooperSurgical, Inc.
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

    reason.potency_specification_failure · v1.0.0

    may not meet specification