Recall Z-1180-2016
Steris Corporation · initiated December 4, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
Details
- Recall number
- Z-1180-2016
- Initiated
- December 4, 2015
- Terminated
- August 26, 2016
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 809 units
- Distribution
- Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
- Recalling firm
- Steris Corporation, Mentor, OH