Z-2147-2015Class II

Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as...

Name: Z-2147-2015 Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as...
Creator: CooperSurgical, Inc.
Published: 2015-07-06
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-07-06 / Terminated

FDA source

CooperSurgical, Inc. began a recall of Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL... on 2015-07-06. FDA classified it as Class II and gives the reason as "Product marketed without a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2147-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-06
Posted: 2015-07-20
Terminated: 2016-06-14
Recalling firm: CooperSurgical, Inc.
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
Product code: MPO Infant Heel Warmer (Chemical Heat Pack)
Reason for recall: Product marketed without a 510(k)
FDA 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 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.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2147-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2147-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code MPO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)