Allen, TX, United States
Quest Medical, Inc. recalls
3 recalls recorded since 2018, most recently on 14 July 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 14 July 2023
- 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.
- Distribution
- US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0197-2024
- 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 sit
Ongoing Class II Medical devices
- Recall started
- 23 December 2022
- Reason
- Delivery Sets may have tubing that could become detached that could result in patient infection.
- Distribution
- US Nationwide distribution in the state of MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1100-2023
- Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
Terminated Class II Medical devices
- Recall started
- 17 December 2019
- Terminated
- 17 April 2024
- Reason
- Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
- Distribution
- US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2107-2020
- Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top cov
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.