ICU Medical recalls specific IV sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold. Affected units include those with purple rings and lot 3459160. Stop using immediately to prevent injury.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
ICU Medical is recalling IV sets with NanoClave manifolds that may leak or separate, causing injury. This affects specific models sold with purple rings and lot number 3459160. Users should stop using these sets immediately to avoid potential injury.
The female luer connector may separate from the NanoClave manifold, causing leaks or disconnection during IV use. This can lead to injury from fluid leakage or improper administration of medication.
Healthcare professionals using the recalled IV sets are most at risk. Patients receiving IV treatments with these sets could experience injury from leaks or separation.
Check for purple rings on the NanoClave manifold. The affected units have lot number 3459160 and expiration date 05/01/2022. The item number is 011-AM6129.
Discontinue use of the recalled IV sets to prevent potential leaks or separation.
The recalled model is PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings).
Check for purple rings on the NanoClave manifold and lot number 3459160 with expiration date 05/01/2022.
Stop using the set immediately to prevent potential injury from leaks or separation.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2809-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2809-2018 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.
