Recall Z-1180-2016 ยท MED Sterilant, Medical Devices
Steris Corporation
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.
| Date | Dec 4, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers. |
| Quantity | 809 units |
| Distribution | Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation, Jul 5, 2013 |