Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 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. |
| Initiated | 2021-06-09 |
| Classified | 2021-07-19 |
| Terminated | 2023-11-01 |
| Recall number | Z-2095-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-2095-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88173/
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