ICU Medical recalls 50 pouches of NanoClave sets with specific lot numbers due to potential manufacturing defects that may prevent proper sealing with the spike.
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 50 pouches of NanoClave sets with specific lot numbers because a manufacturing defect might prevent the sets from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave sets may have a manufacturing defect that prevents them from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures, potentially causing complications.
Healthcare professionals using these sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check the lot numbers: 4742130, 4803158, 4558617, or 4589967. These sets are sold in pouches with 50 sets per case.
Look for lot numbers 4742130, 4803158, 4558617, or 4589967 on the packaging.
The internal surface may have a manufacturing defect that prevents proper sealing with the spike.
50 pouches per case, with specific lot numbers: 4742130, 4803158, 4558617, and 4589967.
The recall does not require immediate discontinuation; check the lot numbers to determine if your set is affected.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0237-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0237-2021 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.
