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 Recall Z-1180-2016 · Posted None
Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMED
Date Initiated2015-12-04
Date Terminated2016-08-26
Product Quantity809 units
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.
Firm Action
On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.