Recall Z-2094-2021— Cardinal Health 200, LLC

Name: FDA recall Z-2094-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-09

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-06-09, terminated 2023-11-01. It names one FDA 510(k) clearance: K964523. Product: 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. 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..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-06-09
Terminated: 2023-11-01
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K964523 — RECOVER INFANT HEEL WARMER (5100)Florida Medical Industries, Inc.·cleared 1997-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.