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Laparoscopic Manual Instruments and Accessories (2014-11-21)
- Starting date:
- November 21, 2014
- Posting date:
- November 28, 2014
- 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-42697
Recalled Products
Laparoscopic Manual Instruments and Accessories
Reason
The parameters provided in the Laparoscopic Manual Instruments instructions for use (IFU 1000-401-070 revision G or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
Affected products
Laparoscopic Manual Instruments and Accessories
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Stryker Endoscopy
5900 Optical Court
San Jose
95138
California
UNITED STATES