FDAClass IINovember 5, 2025

ICU Medical Double ChemoLock Port Syringe Transfer Set recall

ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

Why was ICU Medical Double ChemoLock Port Syringe Transfer Set 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:10840619061729/Lot: 14393155, 14400613, 14376051

Product
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Recalling firm
ICU Medical, Inc.
Quantity
4000 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