ICU Medical recalls Distale 203cm IV sets with NanoClave manifold due to potential leaks or separation between the female luer and manifold. Affected units have specific lot numbers and expiration dates.
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 certain IV administration sets that may leak or separate at the connection point, which could lead to improper fluid delivery. This recall affects patients receiving IV treatments and requires immediate action to prevent complications.
The NanoClave manifold may develop leaks or separate from the female luer connector, potentially causing fluid to leak out of the IV line or disconnect during use. This could lead to improper fluid delivery or infection risks.
Patients receiving IV treatments using the recalled Distale sets are most at risk. Healthcare providers who use these sets for medical administration are also affected.
Check for the Distale 203 cm (80") Bifuse Ext Set with 6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), and Back Check Valve. The product has a specific lot number (3508532) and expires on 08/01/2022.
Look for the Distale 203 cm (80") Bifuse Ext Set with 6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), and Back Check Valve.
The affected units have lot number 3508532 and expire on 08/01/2022.
The recall is due to the potential for leaks or separation between the female luer and NanoClave manifold, which could cause improper fluid delivery.
Check the product details and lot number to confirm if it's affected; the recall requires verification before taking action.
The recall record does not mention a remedy or fix for the 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-2800-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2800-2018 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.
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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.
