ICU Medical recalls 11-inch NanoClave sets with specific lot numbers due to potential seal failure risk. Affected units may not seal properly with the spike, risking 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 11-inch NanoClave sets with specific lot numbers because a manufacturing defect might prevent the set from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures.
The defect may cause the NanoClave set to fail to seal properly with the spike, which is critical for safe fluid administration. This could lead to improper fluid delivery or contamination during medical procedures.
Healthcare professionals using these sets for medical procedures are most at risk. Patients receiving fluids through these sets could face complications if the seal fails.
Check for lot numbers 4493669 or 4558624 on the packaging. The product is a single-use sterile device sold in pouches of 50 units per case.
Look for lot numbers 4493669 or 4558624 on the packaging to identify affected units.
A manufacturing defect on the internal surface may inhibit proper sealing with the spike, potentially causing improper fluid administration.
Check for lot numbers 4493669 or 4558624 on the packaging. The product is sold in pouches of 50 units per case.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0242-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0242-2021 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.
