Recall record at a glance
| Official record | Z-2095-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cardinal Health 200, LLC |
| Report date | Jul 28, 2021 |
| Recall initiation date | Jun 9, 2021 |
| Quantity | 2,911,064 units |
| Location | Mansfield, MA, United States |
Official product description
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
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.