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STERI-VAC GAS STERILIZER/AERATOR (2016-01-29)
- Starting date:
- January 29, 2016
- Posting date:
- August 5, 2016
- 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-59692
Affected products
A. STERI-VAC GAS STERILIZER/AERATOR
Reason
During inspection of incoming components from a supplier, 3M discovered a valve with incorrectly labeled "input" and "output" orientation. Identified in a single lot of 100 valves, this defect can result in the valve being installed backwards, creating a remote possibility of valve failure. Because one of the uses for these valves is to admit air into the sterilizer chamber, and also prevent EO (ethylene oxide) from escaping, a failure may result in EO being vented outside the sealed chamber during a limited period (
Affected products
A. STERI-VAC GAS STERILIZER/AERATOR
Lot or serial number
722614
722615
Model or catalog number
5XL
8XL
Companies
- Manufacturer
-
3M Health Care
2510 Conway Avenue
St. Paul
Minnesota
UNITED STATES
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