FDA Recall
Terminated
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.
Recall: Z-1180-2016
·
Initiated December 4, 2015
Recall
- Recall Number
- Z-1180-2016
- Event Number
- 73009
- Firm
- Steris Corporation
- FEI Number
- 1527821
- Product Code
- MED
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 4, 2015
- Terminated
- August 26, 2016
- Address
- 5960 Heisley Rd, Mentor, OH, 44060-1834
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
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.
Action
On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
Distribution
Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
Quantity
809 units