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U.S. Department of Health and Human Services

Class 2 Device Recall WarmGel Infant Heel Warmer

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  Class 2 Device Recall WarmGel Infant Heel Warmer see related information
Date Initiated by Firm July 06, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-2147-2015
Recall Event ID 71597
Product Classification Infant heel warmer (chemical heat pack) - Product Code MPO
Product 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
Code Information All lot numbers
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
75 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Nana Banafo
203-540-9654
Manufacturer Reason
for Recall		 Product marketed without a 510(k)
FDA Determined
Cause 2		 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 CooperSurgical at 203 601 5200 Ext. 310
Quantity in Commerce 6,344,700
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.
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.
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