ICU Medical recalls ChemoLock w/Mini Bag Spike (Lot:1438522:14385224) in Canada due to potential port weld separation causing leaks. Affected users should contact for remedy.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling ChemoLock w/Mini Bag Spike devices sold in Canada because the port weld might break during use, causing leaks. This could lead to medication exposure or contamination risks for patients.
The port weld in the drug transfer device can separate or break during use, potentially causing leaks. This could expose patients to medication or cause contamination. Leaks might lead to improper drug delivery or infection risks.
Healthcare professionals using the ChemoLock w/Mini Bag Spike in Canada are most at risk. Patients receiving chemotherapy through this device may also be affected.
Check for the product name 'ChemoLock w/Mini Bag Spike' and lot number 14385224. The device was distributed in Canada.
Reach out to ICU Medical for instructions on how to handle the recalled device.
The recall indicates a potential risk of port weld separation causing leaks, so it is not recommended for use until the manufacturer provides a remedy.
Contact ICU Medical directly for instructions on handling the recalled device.
Yes, the lot number 14385224 is associated with this recall in Canada.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0355-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0355-2026 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
