FDA Medical devices recall ·
ChemoLock Close Vial Spike recall
- Recall number
- Z-0652-2025
- Date
- (initiated November 6, 2024)
- Company / brand
- ICU Medical, Inc.
951 Calle Amanecer, San Clemente, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6000 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to finished goods incorrectly packaged and labeled.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938
Distribution
Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
States: Illinois
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0652-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.