ICU Medical recalls 50-pouch NanoClave sets with specific lot numbers due to a potential manufacturing defect that may prevent proper sealing 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 50-pouch sets of NanoClave medical devices because a manufacturing defect might prevent the device from sealing properly with the spike. This could lead to improper fluid administration during medical procedures.
The NanoClave device has a potential manufacturing defect on its internal surface that may prevent it from sealing correctly with the spike. This could lead to improper fluid administration if the seal fails during use.
Healthcare professionals using the NanoClave sets for fluid administration in medical settings. Patients receiving treatments through these devices are at risk if the seal fails.
Check for lot numbers 4600271 or 4537220 on the packaging. The product is sold in 50-pouch sets with a specific UDI code format.
Look for lot numbers 4600271 or 4537220 on the packaging to identify affected units.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the spike.
Check for lot numbers 4600271 or 4537220 on the packaging. The product is sold in 50-pouch sets with a specific UDI code format.
The recall does not specify a remedy, so contact ICU Medical directly 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-0273-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0273-2021 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.
