ICU Medical recalls 1.5ml NanoClave sets with specific lot numbers due to potential manufacturing defect that may prevent proper sealing with the spike. Affected units include 50 pouches per case.
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 1.5ml NanoClave sets that may not seal properly with the spike due to a manufacturing defect. This could lead to improper administration of fluids during medical procedures.
The manufacturing defect on the internal surface of the NanoClave may prevent it from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments with these sets could be affected if the seal fails.
Check the lot numbers: 4536743, 4573956, 4589954, or 4711180. The product is a single-use sterile device sold in pouches of 50 units per case.
Verify the lot numbers on the product: 4536743, 4573956, 4589954, or 4711180.
The internal surface of the NanoClave may have a manufacturing defect that prevents proper sealing with the spike.
50 pouches per case, with specific lot numbers: 4536743, 4573956, 4589954, and 4711180.
The recall does not specify a stop-use action; the hazard is low risk and the remedy is not stated.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0231-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0231-2021 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.
