Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets w
FDA device recall Z-0197-2024 · posted 2023-10-28 · Open, Classified
Recall details
- Recalling firm
- Quest Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 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
- Date initiated
- 2023-07-14
- Date posted
- 2023-10-28
- Location
- Allen, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Q2 Intravenous Adminstration Sets and Extension Sets (K151079) | Quest Medical, Inc. | 2015-09-30 |