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