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.
- Company
- Quest Medical, Inc.
- Recall Initiated
- July 14, 2023
- Posted
- October 28, 2023
- Recall Number
- Z-0197-2024
- Quantity
- 17,700 units
- Firm Location
- Allen, TX
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
Lot / Code Info
Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007
Root Cause
Material/Component Contamination
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.