ICU Medical recalls 50 pouches of MicroClave sets with specific lot numbers due to a potential manufacturing defect that may prevent proper sealing with the spike. Affected units could lead to improper administration of fluids.
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 MicroCl:ave sets that may have a manufacturing defect causing improper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The defect may prevent the NanoClave spike from sealing properly with the set, potentially leading to improper fluid administration. This could cause complications if the seal fails during use.
Healthcare professionals using the MicroClave sets for intravenous fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for the lot number 4572133 on the packaging. The product is a single-use sterile set sold in pouches of 50 units.
Look for the lot number 4572133 on the packaging to confirm if the product is affected.
The affected lot number is 4572133.
50 pouches per case, each pouch contains 1 unit.
The sets may have a manufacturing defect that could prevent proper sealing with the spike, potentially leading to improper fluid administration.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0247-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0247-2021 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.
