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MedStream MS984

by Medical Specialties Distributors, LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 ongoing

Recall on shared 510(k) K964435; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842472100822 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

100 recalls · 4 ongoing · FDA

    • Ongoing Z-3157-2026 FDA Class II initiated 12 May 2026 on shared 510(k) K964435

    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 on shared 510(k) K964435

    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 on shared 510(k) K964435

    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 on shared 510(k) K964435

    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 on shared 510(k) K964435
    • Terminated Z-0957-2021 FDA Class II initiated 2 Dec 2020 on shared 510(k) K964435
    • Terminated Z-0955-2021 FDA Class II initiated 2 Dec 2020 on shared 510(k) K964435
    • Terminated Z-0956-2021 FDA Class II initiated 2 Dec 2020 on shared 510(k) K964435

    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 on shared 510(k) K964435

    Incorrect filter assemblies in IV administration set.

  • 8 recalls, same reason

    • Terminated Z-1915-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1913-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1911-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1920-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1914-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1919-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1917-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435
    • Terminated Z-1918-2020 FDA Class II initiated 4 Oct 2019 on shared 510(k) K964435

    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 on shared 510(k) K964435

    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 on shared 510(k) K964435
    • Terminated Z-2808-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2811-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2816-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2812-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2800-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2813-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2815-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2799-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2814-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2797-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2804-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2798-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2806-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435
    • Terminated Z-2810-2018 FDA Class II initiated 1 Mar 2018 on shared 510(k) K964435

    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.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MedStream
Generic Name
Neutral-pressure intravenous line needleless valve-connector
Model / Ref / Catalog
MS984
Primary DI / UDI-DI
00842472100822
510(k) Number
FDA Product Code
LHI
GMDN Term
Neutral-pressure intravenous line needleless valve-connector
Device Class
Class II
Regulation Number
880.5440
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K964435)

Show all (12)

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No