FDA Medical Device Recalls (openFDA)
Quest Medical, Inc.: 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.
- Recall number
- Z-0197-2024
- Recalling firm
- Quest Medical, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2023-07-14
- Posted
- 2023-10-28
- Terminated
- not on file
- 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.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 17,700 units
- Distribution
- US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada
- Lot, serial or model codes
- Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007
- 510(k) numbers
- ["K151079"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3001665800
- Firm city
- Allen
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28