Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 ...
FDA Device Recall #Z-1596-2013 — Class II — March 4, 2013
Recall Summary
| Recall Number | Z-1596-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 4, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Steris Corporation |
| Location | Mentor, OH |
| Product Type | Devices |
| Quantity | QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0 |
Product Description
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
Reason for Recall
During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
Distribution Pattern
Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
Lot / Code Information
LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
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.