Health product recall

CU-1000 Halogen Curing Light (2018-04-06)

Starting date:
April 6, 2018
Posting date:
June 6, 2018
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-66976

Affected products

CU-1000 Halogen Curing Light

Reason

Henry Schein Inc. is initiating a voluntary product recall for the Henry Schein CU-1000 Halogen Light for Serial Number 17c0001 to 17c0252. The manufacturer has stated that the heat shield/filter is missing inside nose cone. This will result in excessive heat transferred to patient, causing discomfort and burning sensation.

Affected products

CU-1000 Halogen Curing Light

Lot or serial number

17C0001 to 17C0252

Model or catalog number

9004542

Companies
Manufacturer

HENRY SCHEIN Inc.

135 Duryea Road

Melville

11747

New York

UNITED STATES