ICU Medical recalls 1 unit of ChemoLock Bag Spike (REF: CL-10-1:10) due to potential port weld separation causing leaks during use. Affected units have specific UDI and lot numbers.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical is recalling one ChemoLock Bag Spike unit (REF: CL-10-10) because the port weld might break during use, causing a leak. This could lead to medication exposure or contamination risks for patients.
The port weld in the ChemoLock Bag Spike could separate or break during use, which might cause a leak of medication. This leak could lead to contamination or exposure risks for patients or healthcare workers.
Patients using this specific ChemoLock Bag Spike unit for chemotherapy may be affected. The risk is low since only one unit is recalled and the hazard involves potential leaks rather than immediate injury.
Check for the product reference number CL-10-10 and unique identifier 10887709071022 with lot number 14397202. Only one unit is affected by this recall.
Verify the product reference number CL-10-10 and unique identifier 10887709071022 with lot number 14397202 to confirm if your unit is affected.
Only 1 unit (REF: CL-10-10) is affected by this recall.
The port weld breaking could cause a leak of medication, potentially leading to contamination or exposure risks.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0328-2026 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.
