ICU Medical recalls 50-pouch sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the spike, requiring immediate action.
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-pouch sets of 22-inch administration sets with specific lot numbers because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave may have a manufacturing defect that prevents it 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 patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for lot numbers 46055:591 or 4727:498 on the packaging. These sets are sold in pouches of 50 units per case.
Look for lot numbers 4605591 or 4727498 on the packaging to identify affected units.
The recall is due to a potential manufacturing defect on the internal surface of the NanoClave that may inhibit proper sealing with the spike.
50 units per pouch, with specific lot numbers 4605591 and 4727498.
Check the lot numbers on the packaging. If you have the affected lot numbers, 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-0254-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0254-2021 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.
