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ICU Medical Z3309

by ICU Medical, Inc.

ICU Medical Z3309 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K964435 on 2 Apr 1997 and listed in FDA GUDID since 31 Oct 2017 (UDI-DI 00887709031050), active as of 22 Oct 2026. 33 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K964435

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887709031050 UDI-DI Date31 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK964435 Date2 Apr 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K964435 decided 2 Apr 1997 Active
  • FDA GUDID UDI-DI 00887709031050 listed 31 Oct 2017 Listed

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

102 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

92 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

GUDID

Trade name
ICU Medical
Generic name
Basic intravenous administration set, noninvasive
Model / reference
Z3309
Primary DI / UDI-DI
00887709031050
510(k) Number
FDA product code
FMG
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K964435)

and 8 more cleared under K964435

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)