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U.S. Department of Health and Human Services

Class 2 Device Recall CoopeSurigcal

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  Class 2 Device Recall CoopeSurigcal see related information
Date Initiated by Firm May 01, 2013
Date Posted April 07, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-1397-2015
Recall Event ID 70368
510(K)Number K934631  
Product Classification Pack, hot or cold, disposable - Product Code IMD
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
Code Information Product with no lot/ expiration date on the product label
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact
203-601-5200
Manufacturer Reason
for Recall		 Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
FDA Determined
Cause 2		 Package design/selection
Action CooperSurgical sent a formal recall notification letter dated April 4, 2015 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical notified consignees affected by this recall via Fedex with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. CooperSurigcal will replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Contact CooperSurgical at 203 601 5200 Ext. 3100 if you have questions. Previously CooperSurgical notified consignees affected by this recall on 5/1/13.
Quantity in Commerce 4,807,566
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMD and Original Applicant = PRISM TECHNOLOGIES, INC.
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