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Health product recall

INFANT HEEL WARMER LIQUID/GEL (2015-08-10)

Starting date:
August 10, 2015
Posting date:
August 24, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-54778

Affected Products

A. INFANT HEEL WARMER LIQUID

B. FISHERBRAND INFANT HEEL WARMER GEL

Reason

This product lacks the requisite FDA clearance for use in an infant population

Affected products

A. INFANT HEEL WARMER LIQUID

Lot or serial number

N/A

Model or catalog number

22024646

Companies
Manufacturer
Coopersurgical Inc.
95 Corporate Drive
Trumbull
Connecticut
UNITED STATES

B. FISHERBRAND INFANT HEEL WARMER GEL
 

Lot or serial number

N/A

Model or catalog number

22024647

Companies
Manufacturer
Coopersurgical Inc.
95 Corporate Drive
Trumbull
Connecticut
UNITED STATES