Q2 Multiport Extension set — Class II medical device recall Z-0197-2024
Ongoing recall by Quest Medical, Inc., reported 2023-11-08, distributed in AL, CA, CO, FL, IL, MI, MN, MO…. For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I
| Recall number | Z-0197-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quest Medical, Inc., Allen, TX, United States |
| Recall initiated | 2023-07-14 |
| Classified | 2023-10-28 |
| Reported by FDA | 2023-11-08 |
| Distributed | AL, CA, CO, FL, IL, MI, MN, MO, MT, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA |
| Countries outside the US | CA |
| Quantity | 17,700 units |
| UPC / GTIN / UDI-DI | 20634624952007 |
| Lot numbers | 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472 |
| Model numbers | 9520 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0197-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.