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Intravascular Administration Set and Extension Set

by Medegen Medical Manufacturing Services

510(k) K051499

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051499 Date22 Jun 2005ClearedStatusActive

Recalls

24 recalls · 10 ongoing · FDA

    • Ongoing Z-2941-2026 FDA Class II initiated 16 Jun 2026

    Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.

  • 9 recalls, same reason

    • Ongoing Z-1753-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1756-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1752-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1755-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1760-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1757-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1759-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1754-2022 FDA Class II initiated 1 Aug 2022
    • Ongoing Z-1758-2022 FDA Class II initiated 1 Aug 2022

    Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

    • Terminated Z-1482-2017 FDA Class II initiated 20 Feb 2017

    CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter.

    • Terminated Z-1464-2017 FDA Class II initiated 20 Feb 2017

    CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.

    • Terminated Z-0931-2014 FDA Class II initiated 16 Jan 2014

    CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

  • 10 recalls, same reason

    • Terminated Z-0596-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0605-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0601-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0604-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0602-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0599-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0600-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0597-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0598-2013 FDA Class II initiated 18 Apr 2012
    • Terminated Z-0603-2013 FDA Class II initiated 18 Apr 2012

    Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

    • Terminated Z-2707-2011 FDA Unclassified (pre-2012) initiated 20 Apr 2011

    Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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