Q2 Multiport Extension set, REF: 9520, Rx Only recallZ-0197-2024 · Quest Medical, Inc. · initiated Jul 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quest Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Material/Component Contamination
What the company is doing
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. 3. Customers who have the affected lot are required to quarantine the units and return the affected product to Quest Medical. A Return Goods Authorization form can be requested using the attached response form. Please note the reconciliation data below: 4. We ask that you fill out the attached response form to provide us with a clear understanding of the availability of any additional product in your possession. 5. If you are a distributor of Quest Medical products you must contact your customers that received these devices and ensure they take action to immediately stop using the device.
Recall details
- Recall number
- Z-0197-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2023
- Posted by the FDA
- Oct 28, 2023
- Recalling firm
- Quest Medical, Inc.
- Quantity
- 17,700 units
- Product code
- FPA
- FDA submissions
- K151079
- Distribution
- US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada
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.
Code information (models, lots, serial numbers)
Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Q2 Multiport Extension Set 9520Quest Medical Inc · Set, Administration, Intravascular1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page