ICU Medical recalls 50-pouch cases of smallbore pressure infusion sets with potential seal failure risk. Affected units have specific lot numbers and may cause improper fluid delivery during medical procedures.
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. This could lead to fluid delivery issues 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 sealing properly with the NanoClave spike. This could result in improper fluid delivery during medical procedures if the set is used without a proper seal.
Healthcare professionals using these sets for medical fluid delivery are most at risk. Patients receiving treatment with the affected sets could experience improper fluid delivery.
Check for lot numbers 4515232 or 4572761 on the packaging. The product is a 7-inch (18 cm) smallbore pressure infusion set with a purple ring T-connector, sold in 50-pouch cases.
Look for lot numbers 4515232 or 4572761 on the packaging to identify affected units.
The internal surface of the NanoClave component may have a manufacturing defect that inhibits a proper seal with the NanoClave spike.
Check for lot numbers 4515232 or 4572761 on the packaging. The product is a 7-inch (18 cm) smallbore pressure infusion set with a purple ring T-connector, sold in 50-pouch cases.
The recall record 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-0197-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0197-2021 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.
