Z-2095-2021Class II

Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is...

Name: Z-2095-2021 Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is...
Creator: Cardinal Health 200, LLC
Published: 2021-06-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-06-09 / Terminated / root cause: packaging

FDA source

Cardinal Health 200, LLC began a recall of Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the... on 2021-06-09. FDA classified it as Class II and gives the reason as "A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto...". 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-2095-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-09
Posted: 2021-07-19
Terminated: 2023-11-01
Recalling firm: Medtronic, Inc.
Product: Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
Product code: MPO Infant Heel Warmer (Chemical Heat Pack)
Reason for recall: A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Cardinal Health issued a "MEDICAL DEVICE PRODUCT ADVISORY" letter and Acknowledgement Form dated 6/9/2021 via overnight mail to the direct consignees on June 09, 2021. Letters states reason for issuance, health risk associated and action to take: The caution statement on the labeling will be updated to remind the user to activate away from face and infant. The full caution statement will now state: Caution: Activate away from face and infant. If pack ruptures or contents leak, flush contact area with water. Discard pack. If redness or irritation persists, consult a physician. What actions are needed from the Customer? Please review this enhanced caution statement with your staff to ensure product activation is performed away from the face and infant. 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. In the event you have experienced quality problems or adverse events related to the products listed above, please contact [email protected]
Quantity in commerce: 2,911,064 units
Distribution: US Nationwide Distribution to states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA ,ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2094-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19
Z-2095-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-19

Product code MPO

K964523Class IRecover Infant Heel Warmer (5100)Florida Medical Industries, Inc. / cleared 1997-02-10

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)