ICU Medical recalls 6-Port NanoClave Manifold sets with specific lot numbers due to potential seal failure. Affected units may not seal properly with the spike, risking improper fluid administration. Check your lot numbers and contact for details.
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
ICU Medical is recalling 6-Port NanoClave Manifold sets with specific lot numbers because a manufacturing defect might prevent proper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave manifold to fail to seal properly with the spike, which could lead to improper fluid administration during medical procedures. This might result in incorrect fluid delivery or contamination risks.
Healthcare professionals using the NanoClave sets for medical fluid administration are most at risk. Patients receiving fluids through these sets could be affected if the seal fails.
Check the lot numbers listed: 4542066, 4549203, 4558619, 4589971, 4605186, 4733735. The product is a single-use sterile device sold in pouches of 50 units per case.
Verify your product's lot numbers against the listed numbers: 4542066, 4549203, 4558619, 4589971, 4605186, 4733735.
The recall states a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.
1 unit per pouch, 50 pouches per case, with specific lot numbers listed.
The recall record shows no remedy is specified.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0239-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0239-2021 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.
