ICU Medical recalls 50-pouch sets of NanoClave transfer sets with a potential seal defect that could cause improper administration of fluids. Affected units have specific lot numbers and UDI codes.
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 certain NanoClave transfer sets that may have a manufacturing defect preventing proper sealing with the spike. This could lead to improper fluid administration during medical procedures.
The defect may prevent the transfer set from creating a proper seal with the NanoClave spike. This could result in improper fluid administration during medical procedures, potentially causing complications for patients.
Healthcare professionals using the NanoClave transfer 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 4590844 on the packaging. The product includes a unique device identifier (UDI) code starting with (01)10887709066417. These sets are sold in 50-pouch cases.
Look for the lot number 4590844 and UDI code starting with (01)10887709066417 on the packaging.
The recall states there is a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
Check for the lot number 4590844 and UDI code starting with (01)10887709066417 on the packaging. These sets come in 50-pouch cases.
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-0195-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0195-2021 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.
