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Health product recall

System 1 Express Quick Connect (QFC1716INT) (2013-12-18)

Starting date:
December 18, 2013
Posting date:
January 24, 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-37645

Recalled products

  1. System 1 Express Quick Connect (QFC1716INT)

Reason

QFC1716INT is an accessory to the System 1 Express sterile processing system. This quick connect consists of labeling and a flow unit made up of tubing, tethers and adapters used for connecting ports of specified Fujinon devices to flexible processing trays/containers placed within the System 1 Express. Steris has learned that the suction connector barb adapter on the QFC1716INT does not properly fit the suction connector port of the Fujinon 530 series endoscopes, and consequently disconnects from the endoscope prior to reprocessing.

Affected products

A. System 1 Express Quick Connect (QFC1716INT)

Lot or serial number
  • 5984372
  • 6134704
Model or catalog number
  • QXCXXXXINT
Companies
Manufacturer
Steris Corporation
5960 Heisley Road
Mentor
44060
Ohio
UNITED STATES