Z-1301-2015Class II

NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393...

Name: Z-1301-2015 NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393...
Creator: CooperSurgical, Inc.
Published: 2015-01-26
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-01-26 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to... on 2015-01-26. FDA classified it as Class II and gives the reason as "Products without expiration date have the remote potential for minor burn". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1301-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-26
Posted: 2015-03-19
Terminated: 2016-06-14
Recalling firm: CooperSurgical, Inc.
Product: NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: Products without expiration date have the remote potential for minor burn
Root cause tag: packaging
FDA root cause: Package design/selection
Action: CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to 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.
Quantity in commerce: 4938266 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
Product codes and lots: Products without an expiration date and lot number

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1298-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-19
Z-1299-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-19
Z-1300-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-19
Z-1301-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-19

Product code IMD

K912715Class IInstant Warm Gel PackPrism Technologies, Inc. / cleared 1991-10-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)