CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant H

FDA device recall Z-1397-2015 · posted 2015-04-07 · Terminated

Recall details

Recalling firm

CooperSurgical, Inc.

Reason for recall

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

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

IMD

Quantity affected

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

Date initiated

2013-05-01

Date posted

2015-04-07

Date terminated

2016-06-14

Location

Trumbull, CT

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