ICU Medical CH3327

• FDA 510(k) K081361 decided 28 Aug 2008 Active
• FDA GUDID UDI-DI 00840619053642 listed 27 Jul 2021 Listed

• • Ongoing Z-3158-2026 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-3160-2026 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.

• 2 recalls, same reason

  • Ongoing Z-1565-2021 FDA Class II ·initiated 16 Mar 2021
  • Ongoing Z-1566-2021 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-0701-2021 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.

• 2 recalls, same reason

  • Terminated Z-1092-2019 FDA Class I ·initiated 21 Feb 2019
  • Terminated Z-1093-2019 FDA Class I ·initiated 21 Feb 2019

  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.

1. 28 Aug 2008 Cleared FDA 510(k) K081361
2. 21 Feb 2019 Recall initiated FDA recalls Z-1092-2019
3. 21 Feb 2019 Recall initiated FDA recalls Z-1093-2019
4. 31 Aug 2020 Recall initiated FDA recalls Z-0701-2021
5. 16 Mar 2021 Recall initiated FDA recalls Z-1565-2021
6. 16 Mar 2021 Recall initiated FDA recalls Z-1566-2021
7. 27 Jul 2021 Listed FDA GUDID 00840619053642
8. 12 May 2026 Recall initiated FDA recalls Z-3158-2026
9. 12 May 2026 Recall initiated FDA recalls Z-3160-2026

Trade name

ICU Medical

Generic name

Intravenous administration tubing extension set

Model / Ref / Catalog

CH3327

Primary DI / UDI-DI

00840619053642

510(k) Number

K081361 ↗

FDA product code

FPA

GMDN term

Intravenous administration tubing extension set

Device class

Class II

Regulation number

880.5440

GUDID distribution status

In Commercial Distribution

Category: Intravenous administration tubing extension set

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