Z-0652-2025 Class II Ongoing

Recalled by ICU Medical, Inc. — San Clemente, CA

Recall Details

Product Type
Devices
Report Date
December 18, 2024
Initiation Date
November 6, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6000 units

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.

Reason for Recall

Due to finished goods incorrectly packaged and labeled.

Distribution Pattern

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

Code Information

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