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Recall Observatory FDA recall evidence

Device 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.

Z-1180-2016

December 04, 2015

Class II

Product summary

Firm
Steris Corporation
Event
Event 73009
Status
Terminated
Classification
Class II
Quantity
809 units
Official record key
device-enforcement:Z-1180-2016

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.