Recall Z-2094-2021 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
Cardinal Health 200, LLC
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T 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
| Date | Jun 9, 2021 |
| 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. |
| 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 ar |
| Quantity | 926,425 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964523 | RECOVER INFANT HEEL WARMER (5100) Florida Medical Industries, Inc., Feb 10, 1997 |