Z-2095-2021 Class II Terminated
FDA device recall Z-2095-2021 was initiated by Cardinal Health 200, LLC on June 9, 2021 and is designated Class II. 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 u… The recall status is terminated (terminated November 1, 2023). Affected quantity: 2,911,064 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- November 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,911,064 units
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
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.
Distribution Pattern
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.
Code Information
All lots