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M11 Ultraclave Steam Sterilizer (March 15, 2012)
- Starting date:
- March 15, 2012
- Posting date:
- April 30, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72543
Reason
The recall has been issued due to the Sterilizer's door inadvertently opening, while the unit is cycling. This occurs when the user does not properly latch the door and the unit fails to detect the door as improperly closed. The failure of the detection mechanism has been attributed to one of the following failures. Door switch failed closed, short in the capacitor across the door switch, short across switch leads, firmware error or intentional tampering.
Affected products
M11 Ultraclave Steam Sterilizer(2012-03-15)
Lot or serial number
All lots
Model or catalog number
M11-001, M11-001R, M11-002, M11-002R, M11-003, M11-004, M11-005, M11-006, M11D-001, M11D-002
Companies
- Manufacturer
- Not Applicable
- Date modified: