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