FDA-Device2015-04-15Class II

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

CooperSurgical, Inc.
Hazard

Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

Sold states
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
Affected count
4,807,566
Manufactured in
75 Corporate Dr, N/A, Trumbull, CT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1397-2015

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