ICU Medical ChemoLock Bag Spike recall
ICU Medical ChemoLock Bag Spike REF: CL-10
Why was ICU Medical ChemoLock Bag Spike 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:10887709056968/Lot: 14419330
- Product
- ICU Medical ChemoLock Bag Spike REF: CL-10
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 7850 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)