Fresenius Kabi recalls IVENIX infusion sets with a risk of blood clots if the 200-micron filter is incorrectly positioned. Affected units have model SET-0014-20 and UDI 20811505030034. Contact for return instructions.
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Fresenius Kabi is recalling IVENIX infusion sets that could allow large blood particles to pass through if the filter is misaligned. This poses a risk of blood clots in patients receiving blood products.
The 200-micron drip chamber filter can be incorrectly positioned during assembly, allowing large blood particles to pass into the bloodstream. This could cause blood clots or other complications in patients receiving blood products.
Patients receiving blood products through this infusion set are most at risk. Healthcare providers using the set for blood administration may also be affected.
Check for model number SET-0014-20 and unique device identifier (UDI) 20811505030034 on the product packaging. The product is a 15 mL blood administration set with a mesh filter.
Look for model number SET-0014-20 and UDI 20811505030034 on the packaging or label.
The 200-micron drip chamber filter can be incorrectly positioned during assembly, allowing large blood particles to pass into the bloodstream.
Check for model number SET-0014-20 and UDI 20811505030034. Contact Fresenius Kabi for return instructions.
The recall states a risk of blood clots if the filter is misaligned, but the remedy is not specified in the record.
We’ve drafted a message you can send Fresen:ius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-1869-2025 — Fresen:ius Kabi Fresen:ius Kabi Hello, I own a Fresen:ius Kabi that is covered by recall Z-1869-2025 from Fresen:ius Kabi. 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.
