FDAClass IINovember 5, 2025

ICU Medical ChemoLock" Port recall

ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS

Why was ICU Medical ChemoLock" Port recalled?

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI:00887709094505/Lot: 14407400

Product
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Recalling firm
ICU Medical, Inc.
Quantity
2000 units
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.
Recall date
November 5, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls