ICU Medical recalls 165 cm IV sets with NanoClave manifold due to potential leaks or separation between components. Affected units may cause fluid leakage or disconnection during use. Contact for replacement.
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 165 cm IV sets with Nano:Clave manifolds because they might leak or separate, which could cause fluid leakage or disconnection during use. This affects medical devices used for administering fluids to patients.
The NanoClave manifold may leak or separate from the female luer connector, potentially causing fluid leakage or disconnection during IV administration. This could lead to improper fluid delivery or patient discomfort.
Healthcare professionals using IV sets for patient fluid administration. Patients receiving IV treatment are at risk if the set separates or leaks.
Look for the 165 cm (65") PUR Smallbore Ext Set with 3-Port NanoClave Manifold, Check Valve, and NanoClave. The item number is 011-AM3003. Units were sold with lot number 3297342 and expiration date 07/01/2021.
Inspect the IV set for signs of leakage or separation between the female luer and NanoClave manifold.
Reach out to ICU Medical for a replacement or repair if the set shows signs of leakage or separation.
ICU Medical is recalling these IV sets due to potential leaks or separation between the female luer and NanoClave manifold, which could cause fluid leakage or disconnection during use.
Check for leaks or separation between components. If issues are found, contact ICU Medical for a replacement or repair.
Yes, patients receiving IV treatment using this specific set could be at risk if the set separates or leaks.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2798-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2798-2018 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.
