Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous flu...
FDA Device Recall #Z-0197-2024 — Class II — July 14, 2023
Recall Summary
| Recall Number | Z-0197-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Quest Medical, Inc. |
| Location | Allen, TX |
| Product Type | Devices |
| Quantity | 17,700 units |
Product Description
Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
Reason for Recall
For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Distribution Pattern
US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada
Lot / Code Information
Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007
Other Recalls from Quest Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1100-2023 | Class II | Precision Delivery Set with Filter, REF: PD06F;... | Dec 23, 2022 |
| Z-2107-2020 | Class II | Ref 801168, MPS Top Cover Replacement Kit, 1 UN... | Dec 17, 2019 |
| Z-0361-2016 | Class II | Model 5001102 MPS Delivery Set w/ arrest agent ... | Oct 28, 2015 |
| Z-1368-2015 | Class II | LIS27T - Lacrimal Intubation Set RX Only Steri... | Feb 26, 2015 |
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.