Recall Z-0197-2024— Quest Medical, Inc.

Name: FDA recall Z-0197-2024
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Class II · Ongoing

Class II FDA medical device recall by Quest Medical, Inc., initiated 2023-07-14. It names one FDA 510(k) clearance: K151079. Product: 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 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..

Recalling firm: Quest Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-14
Firm location: Allen, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K151079 — Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc.·cleared 2015-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.