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Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737IN...

FDA Recall #Z-1180-2016 — Class II — December 4, 2015

Recall #Z-1180-2016 Date: December 4, 2015 Classification: Class II Status: Terminated

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.

Recalling Firm

Steris Corporation — Mentor, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

809 units

Distribution

Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.

Code Information

All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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