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

• Reason
• Affected products

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