Summary
The FDA issued a Class II for ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 by ICU Medical, Inc.. Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak..
Details
Source
Device Recall
External ID
Z-0363-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Lot/Code Info: Lot:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan
Quantity Affected: 134700 units
Reason for Recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Distribution
Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-08
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 284 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-0363-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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