This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
SYSTEM 1 EXPRESS - QUICK CONNECT KIT (2016-01-18)
- Starting date:
- January 18, 2016
- Posting date:
- January 18, 2016
- 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-56642
Affected Products
A. SYSTEM 1 EXPRESS - QUICK CONNECT KIT
Reason
Quick Connects provide directed flow of processing fluids (sterilant use dilution and rinse water) into the internal lumens of specifically identified endoscopes via adapters which connect to the endoscope ports. Each quick connect contains a flow unit consisting of tubing, tethers, and adapters for connecting the medical device to the system 1 express processing tray to achieve liquid chemical sterilization. Steris has learned that one of the Hysteroscope Models (Karl Storz 11264BBU1) listed for processing in two existing quick connects has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions. A user who connects the Karl Storz 11264BBU1 Hysteroscope according to the processing instructions will observe an unused port adapter on the quick connect.
Affected products
A. SYSTEM 1 EXPRESS - QUICK CONNECT KIT
Lot or serial number
All lots.
Model or catalog number
QKC1736INT QKC1737INT
Companies
- Manufacturer
-
Steris Canada Corporation
490 Boul. Armand-Paris
Quebec
G1C 8A3
Quebec
CANADA