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Sterrad Sterilizers (2013-11-07)
- Starting date:
- November 7, 2013
- Posting date:
- December 17, 2013
- 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-37221
Recalled products
- Sterrad 100 S Sterilizer
- Sterrad 50 Sterilizer
- Sterrad NX Sterilizer
- Sterrad 100NX Sterilizer
Reason
ASP is notifying users to discontinue processing certain Karl Storz model flexible bronchoscopes and intubation fiberscopes in Sterrad system sterilizers. These endoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (Lumens) for processing in sterrad systems.
Affected products
A. Sterrad 100 S Sterilizer
Lot or serial number
All serial numbers
Model or catalog number
- 10101
Companies
- Manufacturer
-
Advanced Sterilization Products
a Division of Ethicon
33 Technology Drive
Irvine
92618
California
UNITED STATES
B. Sterrad 50 Sterilizer
Lot or serial number
All serial numbers
Model or catalog number
- 10050
Companies
- Manufacturer
-
Advanced Sterilization Products
a Division of Ethicon
33 Technology Drive
Irvine
92618
California
UNITED STATES
C. Sterrad NX Sterilizer
Lot or serial number
All serial numbers
Model or catalog number
- 10033
Companies
- Manufacturer
-
Advanced Sterilization Products
a Division of Ethicon
33 Technology Drive
Irvine
92618
California
UNITED STATES
D. Sterrad 100NX Sterilizer
Lot or serial number
All serial numbers
Model or catalog number
- 10104
Companies
- Manufacturer
-
Advanced Sterilization Products
a Division of Ethicon
33 Technology Drive
Irvine
92618
California
UNITED STATES