Z-0185-2023Class II

Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

Name: Z-0185-2023 Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Creator: Cardinal Health 200, LLC
Published: 2022-09-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-09-28 / Open, Classified / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 on 2022-09-28. FDA classified it as Class II and gives the reason as "Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0185-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2022-11-07
Recalling firm: Medtronic, Inc.
Product: Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Product code: IME Pack, Hot Or Cold, Reusable
Reason for recall: Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: Cardinal Health sent an URGENT:MEDICAL DEVICE PRODUCT CORRECTION on 10/03/2022 by overnight mail. The notice explained the issue and requested the following: "Actions Required: 1. COMMUNICATE with all personnel that utilize these gel packs regarding appropriate use. 2. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product correction notice and share a copy of this notice. 3. POST a copy of this notification in your storeroom where the product is stored 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether or not you have affected product." Additional Information: "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: 1915308 units
Distribution: nationwide and Canada
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0185-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0185-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0186-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0187-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0188-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0189-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0190-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0191-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07
Z-0192-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07

Product code IME

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)