Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated
Summary
The FDA issued a Class II for Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T by Cardinal Health 200, LLC. 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 m.
Details
Source
Device Recall
External ID
Z-2094-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: All lots
Quantity Affected: 926,425 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-09
Company
Mansfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2094-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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