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U.S. Department of Health and Human Services

Class 2 Device Recall Q2 Multiport IV sets and Extension Sets

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 Class 2 Device Recall Q2 Multiport IV sets and Extension Setssee related information
Date Initiated by FirmJuly 14, 2023
Date PostedOctober 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0197-2024
Recall Event ID 93116
510(K)NumberK151079 
Product Classification Set, administration, intravascular - Product Code FPA
ProductQ2 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 Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007
Recalling Firm/
Manufacturer		 Quest Medical, Inc.
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information ContactJan Hodges
972-390-9800
Manufacturer 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.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 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 in Commerce17,700 units
DistributionUS:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
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