QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for ...
FDA Device Recall #Z-2284-2012 — Class II — August 10, 2012
Recall Summary
| Recall Number | Z-2284-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 10, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Steris Corporation |
| Location | Mentor, OH |
| Product Type | Devices |
| Quantity | 64 units |
Product Description
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Reason for Recall
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Distribution Pattern
Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.
Lot / Code Information
Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
Other Recalls from Steris Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0910-2026 | Class II | AMSCO 7053HP Washer/Disinfector Model/Catalog... | Nov 19, 2025 |
| Z-0909-2026 | Class II | AMSCO 7052HP Washer/Disinfector Model/Catalog ... | Nov 19, 2025 |
| Z-2178-2025 | Class II | Dual Flat Panel Monitor (DFPM) accessories for ... | Jun 23, 2025 |
| Z-2177-2025 | Class II | Dual Flat Panel Monitor (DFPM) accessories for ... | Jun 23, 2025 |
| Z-1361-2026 | Class II | Barco MNA with the HexaVue IP Integration Syste... | May 23, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.