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12-Instrument Sterilization Tray (2014-04-25)
- Starting date:
- April 25, 2014
- 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-39479
Recalled products
- 12-Instrument Sterilization Tray
Reason
Gravity sterilization parameters provided in the 12 instrument sterilization reprocessing guide (1000400920 Revision D) did not fully consider all worst-case scenarios during validation testing.
Affected products
A. 12-Instrument Sterilization Tray
Lot or serial number
All lots
Model or catalog number
- 242-000-012
Companies
- Manufacturer
-
Stryker Endoscopy
5900 Optical Court
San Jose
95138
California
UNITED STATES