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Primary IV Set

by ICU Medical, Inc.

510(k) K964435

Primary IV Set is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K964435 on 2 Apr 1997, active as of 22 Oct 2026. 33 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964435 Date2 Apr 1997ClearedStatusActive

Official records

Recalls

100 recalls · 4 ongoing · FDA

    • Ongoing Z-3157-2026 FDA Class II initiated 12 May 2026

    Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

    • Ongoing Z-3163-2026 FDA Class II initiated 12 May 2026

    Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

    • Ongoing Z-0154-2026 FDA Class I initiated 2 Oct 2025

    IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

    • Ongoing Z-1721-2022 FDA Class II initiated 1 Aug 2022

    Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

  • 4 recalls, same reason

    • Terminated Z-0958-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0957-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0955-2021 FDA Class II initiated 2 Dec 2020
    • Terminated Z-0956-2021 FDA Class II initiated 2 Dec 2020

    Due to the incorrect filter assembly.

  • 67 recalls, same reason

    • Terminated Z-0191-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0217-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0221-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0183-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0189-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0253-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0255-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0244-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0211-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0195-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0225-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0184-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0202-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0194-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0246-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0251-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0223-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0254-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0210-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0219-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0199-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0260-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0185-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0243-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0214-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0234-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0206-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0196-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0226-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0237-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0190-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0242-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0224-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0188-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0209-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0240-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0222-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0241-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0218-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0239-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0233-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0232-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0235-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0205-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0229-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0231-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0249-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0238-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0198-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0256-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0236-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0200-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0262-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0187-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0208-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0207-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0203-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0228-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0230-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0215-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0247-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0258-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0227-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0186-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0259-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0245-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435
    • Terminated Z-0216-2021 FDA Class II initiated 6 Jul 2020 on shared 510(k) K964435

    Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

    • Terminated Z-0511-2021 FDA Class II initiated 1 Jul 2020

    Incorrect filter assemblies in IV administration set.

  • 8 recalls, same reason

    • Terminated Z-1915-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1913-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1911-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1920-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1914-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1919-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1917-2020 FDA Class II initiated 4 Oct 2019
    • Terminated Z-1918-2020 FDA Class II initiated 4 Oct 2019

    There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

    • Completed Z-0069-2019 FDA Class II initiated 20 Aug 2018

    Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.

  • 15 recalls, same reason

    • Terminated Z-2801-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2808-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2811-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2816-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2812-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2800-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2813-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2815-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2799-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2814-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2797-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2804-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2798-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2806-2018 FDA Class II initiated 1 Mar 2018
    • Terminated Z-2810-2018 FDA Class II initiated 1 Mar 2018

    ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

101 dated events

  1. Recall initiated FDA recalls Z-0245-2021
  2. Recall initiated FDA recalls Z-0216-2021
  3. Recall initiated FDA recalls Z-0958-2021
  4. Recall initiated FDA recalls Z-0957-2021
  5. Recall initiated FDA recalls Z-0955-2021
  6. Recall initiated FDA recalls Z-0956-2021
  7. Recall initiated FDA recalls Z-1721-2022
  8. Recall initiated FDA recalls Z-0154-2026
  9. Recall initiated FDA recalls Z-3157-2026
  10. Recall initiated FDA recalls Z-3163-2026

91 earlier events are in the sections above.

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
FMG
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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