Recall Z-1397-2015 ยท IMD Pack, Hot Or Cold, Disposable
CooperSurgical, Inc.
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
| Date | Apr 7, 2015 (initiated May 1, 2013) |
| Status | Terminated |
| Reason | Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification |
| Root 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 o |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934631 | TRANSWARMER Prism Technologies, Inc., Feb 3, 1994 |