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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien/Argyle

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  Class 2 Device Recall Covidien/Argyle see related information
Date Initiated by Firm June 09, 2021
Create Date July 19, 2021
Recall Status1 Terminated 3 on November 01, 2023
Recall Number Z-2095-2021
Recall Event ID 88173
510(K)Number K964523  
Product Classification Infant heel warmer (chemical heat pack) - Product Code MPO
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
Code Information All lots
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
15 Hampshire St Bldg 5
Mansfield MA 02048-1113
Manufacturer 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.
FDA Determined
Cause 2		 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332. In the event you have experienced quality problems or adverse events related to the products listed above, please contact GMB-CAH-Dist-Domestic@cardinalhealth.com
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MPO and Original Applicant = FLORIDA MEDICAL INDUSTRIES, INC.
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