Infant Heel Warmer with/without Attachment Tab (2021-06-10)

Starting date:

June 10, 2021

Posting date:

June 17, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75825

Last updated:
2021-06-17

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  Reason
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  Affected products

Affected Products 

A. Infant Heel Warmer with Attachment Tab

B. Infant Heel Warmer without Attachment Tab

Reason

Cardinal Health is initiating a medical device product advisory to advise customers of a labeling update on its Infant Heel Warmer products. Specifically, a caution statement is being added to remind the user to "activate away from the user’s face and away from the infant and others."

Affected products