# FDA recall Z-0197-2024

> **Quest Medical, Inc.** · Class II · device recall initiated 2023-07-14.

## 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 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

US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada

## Key facts

- **Recall number:** Z-0197-2024
- **Recalling firm:** Quest Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-14
- **Report date:** 2023-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allen, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2024

## Citation

> AI Analytics. FDA recall Z-0197-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0197-2024. Source: US FDA. Licensed CC0.

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