—#142726

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.

FDA product code: MED — Sterilant, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K131078
Affected lot / code info: All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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

Timeline

Recall initiated: 2015-12-04
Terminated: 2016-08-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.