Health product recall

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

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

Infant Heel Warmer with Attachment Tab

Lot or serial number

All lots. 

Model or catalog number

ZMH00002T

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES

Infant Heel Warmer without Attachment Tab

Lot or serial number

All lots. 

Model or catalog number

ZMH00002N

Companies
Manufacturer

Cardinal Health

3651 Birchwood Drive

Waukegan

60085

UNITED STATES