ICU Medical recalls 10-drop admin sets with potential 15-drop cannula causing under-delivery of critical medication. Affected units sold outside US. Stop using immediately to prevent serious health risks.
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
ICU Medical recalls certain IV administration sets that may have a 15-drop cannula instead of the required 10-drop cannula. This could cause under-delivery of critical medication, risking serious health consequences. The product was not distributed in the US, so US consumers are not affected.
The IV set may contain a 15-drop cannula instead of the required 10-drop cannula. This causes the infusion to deliver less medication than intended, potentially leading to under-delivery of critical drugs. Under-delivery could cause serious health issues if the medication is life-saving.
US consumers are not affected as the product was not distributed within the US. Affected users outside the US may need to check their units.
Check for the product name: 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R. Look for the UDI: (01)00887709063211. The product was not distributed in the US, so US consumers are not affected.
The product was not distributed in the US, so US consumers are not affected. Affected users outside the US should stop using the product to prevent under-delivery of critical medication.
No, the product was not distributed within the US.
Using the product could cause under-delivery of critical medication, potentially leading to serious health consequences.
Check for the product name: 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R and the UDI: (01)00887709063211. The product was not distributed in the US, so US consumers are not affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1912-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
