ICU Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0652-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Product Classification:

Class II

Date Initiated: November 6, 2024

Date Posted: December 18, 2024

Recall Number: Z-0652-2025

Event ID: 95649

Reason for Recall:

Due to finished goods incorrectly packaged and labeled.

Status: Ongoing

Product Quantity: 6000 units

Code Information:

Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938

Distribution Pattern:

Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated