ICU Medical recalls 8" ext sets with MicroClave Clear port that may leak if port weld breaks during use. Affected units sold in Canada with specific lot numbers.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling 8-inch extension sets with a MicroClave Clear port that could leak if the port weld breaks during use. This poses a risk of medication leakage, which could affect patient safety.
The port weld in the drug transfer device may separate or break during use, causing medication to leak. This could lead to incorrect dosing or contamination of the patient's treatment.
Healthcare professionals using these sets in medical facilities in Canada are most at risk. Patients receiving treatment with these devices could be affected if the leak occurs.
Check for the product name 'ICU Medical 8" (2:0 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950'. Affected units have lot numbers 14393168 or 14414091 and were distributed in Canada.
Identify the product by its full name and lot numbers (14393168 or 14414091) to confirm if it's affected.
The product may leak if the port weld breaks during use, so it's not safe to use without checking for the recall.
The recall record does not specify a remedy, so contact ICU Medical directly for guidance.
Yes, affected units have lot numbers 14393168 or 14414091.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0358-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0358-2026 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.
