Health product recall

Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series (2018-06-22)

Starting date:
June 22, 2018
Posting date:
July 5, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67182

Affected products

Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series

Reason

Sterilization symbols on labels are conflicting because they indicate two different methods of sterilization (irradiation and ethylene oxide). Ethylene oxide is the correct symbol.

Affected products

Blom-Singer Classic Indwelling Voice Prosthesis - Sterile Series

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IN1608-SO
IN1610-SO
IN1612-SO
IN1614-SO
IN2008-SO
IN2010-SO
IN2012-SO
IN2014-SO

Companies
Manufacturer
FREUDENBERG MEDICAL, LLC
1110 MARK AVENUE
CARPINTERIA
93013-2918
UNITED STATES