Class 2 Device Recall CoopeSurigcal

• Date Initiated by Firm: May 01, 2013
• Date Posted: April 07, 2015
• Recall Status: Terminated 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: 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