PlainRecalls
FDA Devices Moderate Class II Terminated

Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.

Reported: March 23, 2016 Initiated: December 4, 2015 #Z-1180-2016

Product Description

Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.

Reason for Recall

The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.

Details

Recalling Firm
Steris Corporation
Units Affected
809 units
Distribution
Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.. Recalled by Steris Corporation. Units affected: 809 units.
Why was this product recalled?
The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1180-2016.