ICU Medical recalls 85-inch 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 85-inch IV sets with NanoCl:ave manifolds because they might leak or separate, which could cause problems during medical use. This affects specific units sold with certain lot numbers and expiration dates.
The NanoClave manifold may develop leaks or separate from the female luer connector during use. This could lead to improper IV fluid delivery, infection risks, or other medical complications if the connection fails.
Healthcare professionals using IV sets with the NanoClave manifold are most at risk. Patients receiving IV treatments with these sets could face complications if the manifold separates or leaks.
Check for the product name: 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set with 3-Port NanoClave Manifold. Affected units have Lot Number 3424312 and expire by March 1, 2022.
Inspect the connection between the female luer and NanoClave manifold for signs of leakage or separation.
Reach out to ICU Medical for guidance on whether your unit is affected and if a remedy is available.
ICU Medical is expanding their recall to include additional IV sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.
Check for the specific lot number and expiration date on the product. Contact ICU Medical directly for further instructions.
The recall record does not specify a remedy, so contact ICU Medical for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2801-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2801-2018 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.
