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Recall Observatory FDA recall evidence

Device 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.

Z-0197-2024

July 14, 2023

Class II

Product summary

Firm
Quest Medical, Inc.
Event
Event 93116
Status
Ongoing
Classification
Class II
Quantity
17,700 units
Official record key
device-enforcement:Z-0197-2024

Official wording

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.

Code information: Lots: 69083, 69136, 69329, 69330, 69396, 69397, 69471, 69472; UDI: (01)20634624952007

Distribution pattern: US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY OUS: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.