Recall Z-2147-2015 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
CooperSurgical, Inc.
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
| Date | Jul 20, 2015 (initiated Jul 6, 2015) |
| Status | Terminated |
| Reason | Product marketed without a 510(k) |
| Root cause | No Marketing Application |
| Action | CooperSurgical sent an " Urgent WarmGel Infant Heel Warmer" letter dated June 30, 2015, FEDEx, confirmed delivery receipt on July 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CooperSurgical is advising all WarmGel users to review your inventory of this product, remove it from your inventory and discontinue its use. informing them of the reason to cease using the product and either discard or return product to CooperSurgical. Accounts are provided with a response form to complete. Any questions contact Co |
| Quantity | 6,344,700 |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.