Skip to content

ICU Medical CL4161

by ICU Medical, Inc.

ICU Medical CL4161 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K131549 on 26 Jul 2013 and listed in FDA GUDID since 27 Jul 2021 (UDI-DI 00887709121386), active as of 22 Oct 2026. 59 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

50 ongoing

This device is named in the recall

Documents

510(k) K131549

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 Number00887709121386 UDI-DI Date27 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131549 Date26 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131549 decided 26 Jul 2013 Active
  • FDA GUDID UDI-DI 00887709121386 listed 27 Jul 2021 Listed

Recalls

60 recalls · 50 ongoing · FDA

    • Ongoing Z-3161-2026 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-3159-2026 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-2210-2026 FDA Class II initiated 24 Mar 2026

    Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

  • 38 recalls, same reason

    • Ongoing Z-0356-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0351-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0362-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0363-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0358-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0348-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0365-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0336-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0359-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0354-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0332-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0343-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0337-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0347-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0345-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0349-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0333-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0352-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0364-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0340-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0344-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0328-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0350-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0329-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0334-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0335-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0353-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0341-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0346-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0360-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0339-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0331-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0338-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0361-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0357-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0355-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0342-2026 FDA Class II initiated 8 Sep 2025
    • Ongoing Z-0330-2026 FDA Class II initiated 8 Sep 2025

    Port weld of drug transfer device may separate or break during use and potentially result in a leak.

    • Ongoing Z-0652-2025 FDA Class II initiated 6 Nov 2024

    Due to finished goods incorrectly packaged and labeled.

    • Ongoing Z-1681-2022 FDA Class II initiated 27 Jun 2022

    Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

  • 6 recalls, same reason

    • Ongoing Z-1574-2021 FDA Class II initiated 16 Mar 2021
    • Ongoing Z-1571-2021 FDA Class II initiated 16 Mar 2021
    • Ongoing Z-1570-2021 FDA Class II initiated 16 Mar 2021
    • Ongoing Z-1572-2021 FDA Class II initiated 16 Mar 2021
    • Ongoing Z-1573-2021 FDA Class II initiated 16 Mar 2021
    • Ongoing Z-1575-2021 FDA Class II initiated 16 Mar 2021

    Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

    • Ongoing Z-0703-2021 FDA Class II initiated 31 Aug 2020

    Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

    • Terminated Z-1096-2019 FDA Class I initiated 21 Feb 2019 on shared 510(k) K131549

    There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

    • Terminated Z-0805-2019 FDA Class I initiated 3 Jan 2019

    There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

  • 8 recalls, same reason

    • Terminated Z-1261-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1254-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1257-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1259-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1258-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1255-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1256-2016 FDA Class II initiated 25 Feb 2016
    • Terminated Z-1260-2016 FDA Class II initiated 25 Feb 2016

    ICU Medical has identified an issue with a connection in an isolated number of I.V. infusion administration sets that incorporate the ChemLock additive port. In these sets, the connection between the Drip Chamber or Bag Spike and the ChemoLock port has the potential for developing a leak.

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

Timeline

62 dated events

  1. Recall initiated FDA recalls Z-0331-2026
  2. Recall initiated FDA recalls Z-0338-2026
  3. Recall initiated FDA recalls Z-0361-2026
  4. Recall initiated FDA recalls Z-0357-2026
  5. Recall initiated FDA recalls Z-0355-2026
  6. Recall initiated FDA recalls Z-0342-2026
  7. Recall initiated FDA recalls Z-0330-2026
  8. Recall initiated FDA recalls Z-2210-2026
  9. Recall initiated FDA recalls Z-3161-2026
  10. Recall initiated FDA recalls Z-3159-2026

52 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
Medication transfer set
Model / Ref / Catalog
CL4161
Primary DI / UDI-DI
00887709121386
510(k) Number
FDA product code
ONB
GMDN term
Medication transfer set
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medication transfer set

Cleared under the same submission (K131549)

and 8 more cleared under K131549

Similar devices

Other devices filed under FDA product code ONB (Closed antineoplastic and hazardous drug reconstitution and transfer system).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)