Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0652-2025

November 06, 2024

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 95649
Status
Ongoing
Classification
Class II
Quantity
6000 units
Official record key
device-enforcement:Z-0652-2025

Official wording

Reason: Due to finished goods incorrectly packaged and labeled.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to finished goods incorrectly packaged and labeled.