Recall Z-1180-2016— Steris Corporation

Name: FDA recall Z-1180-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-04

Class II · Terminated

Class II FDA medical device recall by Steris Corporation, initiated 2015-12-04, terminated 2016-08-26. It names one FDA 510(k) clearance: K131078. Product: 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: 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..

Recalling firm: Steris Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-12-04
Terminated: 2016-08-26
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation·cleared 2013-07-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.