ICU Medical recalls 38cm IV sets with NanoClave manifold due to potential leaks or separation between components. 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 38 cm IV sets with NanoClave manifolds because they might leak or separate, which could cause problems during medical use. This recall affects specific batches sold with certain expiration dates.
The NanoClave manifold may develop leaks or separate from the female luer connector, potentially causing interruptions in IV flow or contamination. This could lead to treatment delays or infections if the set fails during medical procedures.
Healthcare professionals using these IV sets in medical facilities are most at risk. Patients receiving IV treatments with the recalled sets could face complications if the set fails.
Check for the product name '38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold' with specific lot numbers: 3484175, 3493946, or 3498103. These units expired by July 1, 2022.
Identify the lot number and expiration date on the product label to confirm if it's affected.
Reach out to ICU Medical for guidance on next steps if you have the recalled item.
The recall is due to the potential for leaks or separation between the female luer and NanoClave manifold, which could disrupt IV treatments.
Lot numbers 3484175, 3493946, and 3498103 with expiration dates of July 1, 2022.
The recall record does not mention a fix or remedy, so users should contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2810-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2810-2018 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.
