Recall Z-0197-2024 ยท FPA Set, Administration, Intravascular
Quest Medical, Inc.
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.
| Date | Oct 28, 2023 (initiated Jul 14, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | On July 14, 2023, Quest Medical issued a Voluntary Product recall Notice to affected customers via E-Mail and postal mail. Quest Medical asked consignees 1. If the device is in use, check for the lot number or unique device identifier (UDI). . Affected lots should be replaced immediately. If the lot or UDI cannot be identified replacement should take place. 2. To replace, the administration set should be clamped and removed from the patient. Institutional policies should be followed in replacement of a new manifold and clinical assessment of infection control mitigation should be followed. |
| Quantity | 17,700 units |
| Distribution | US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151079 | Q2 Intravenous Adminstration Sets and Extension Sets Quest Medical, Inc., Sep 30, 2015 |