ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment
Summary
The FDA issued a Class II for ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Dev by ICU Medical, Inc.. Reason: Due to finished goods incorrectly packaged and labeled..
Details
Source
Device Recall
External ID
Z-0652-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
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.
Lot/Code Info: Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938
Quantity Affected: 6000 units
Reason for Recall
Due to finished goods incorrectly packaged and labeled.
Distribution
Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-06
Company
San Clemente, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical, Inc. have FDA actions?
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0652-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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