Z-2147-2023Class II

NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

Name: Z-2147-2023 NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Creator: Cardinal Health 200, LLC
Published: 2023-06-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-06-16 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 on 2023-06-16. FDA classified it as Class II and gives the reason as "Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2147-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-16
Posted: 2023-07-17
Recalling firm: Medtronic, Inc.
Product: NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Product code: MPO Infant Heel Warmer (Chemical Heat Pack)
Reason for recall: Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 06/16/2023 for delivery n 06/19/2023 by FedEx priority overnight. The notice explained the problem, risks, and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product code and lot. Location of product code and lot are shown in above listed table and below example labeling. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether you have affected product or not. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332."
Quantity in commerce: 44,500 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2147-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2147-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17

Product code MPO

K961154Class IBaxter Sodium Acetate Infant Heel WarmerBaxter Healthcare Corp / cleared 1996-06-06

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)