Z-1397-2015 Class II Terminated
FDA device recall Z-1397-2015 was initiated by CooperSurgical, Inc. on May 1, 2013 and is designated Class II. Reason for recall: Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification The recall status is terminated (terminated Jun 14, 2016). Affected quantity: 4,807,566.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 15, 2015
- Initiation Date
- May 1, 2013
- Termination Date
- Jun 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,807,566
Product Description
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
Reason for Recall
Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
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
Code Information
Product with no lot/ expiration date on the product label
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1397-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026