ICU Medical recalls smallbore pressure infusion sets with potential manufacturing defects that may prevent proper sealing with the NanoClave spike. Affected units have specific lot numbers and are used in medical fluid delivery systems.
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 smallbore pressure infusion sets that may have a manufacturing defect causing improper sealing with the NanoClave spike. This could lead to fluid leaks during medical procedures if the set is used without a proper seal.
The internal surface of the NanoClave component may have a manufacturing defect that prevents it from creating a proper seal with the NanoClave spike. This could allow fluid to leak during medical procedures, potentially causing complications for patients.
Healthcare professionals using these sets for medical fluid delivery systems are most at risk. Patients receiving treatments through these sets could experience fluid leaks if the seal fails.
Look for the specific lot number 4603281 on the packaging. The product is a 7-inch (18 cm) smallbore pressure infusion set with a purple NanoClave component, sold in 50-pouch cases.
Verify the lot number on the packaging; affected units have lot number 4603281.
The internal surface of the NanoClave component may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check the lot number on the packaging; affected units have lot number 4603281. The product is a 7-inch (18 cm) smallbore pressure infusion set with a purple NanoClave component.
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-0201-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0201-2021 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.
