ICU Medical recalls 50-pouch cases of smallbore IV sets with a potential manufacturing defect that may inhibit proper seal with the NanoClave spike. Affected units have specific lot numbers.
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 a specific type of IV tubing set that may not seal properly with the NanoClave spike due to a manufacturing defect. This could lead to improper fluid administration during medical procedures.
The internal surface of the NanoClave component may have a manufacturing defect that prevents it from creating a proper seal with the spike. This could allow fluid to leak or not flow correctly during medical procedures.
Healthcare professionals using the recalled IV sets for patient care. Patients receiving treatments through these sets are at risk if the seal fails during administration.
Check for the specific lot numbers: 4590834, 4557481, 4536601, 4724818, or 4733548. The product comes in 50 pouches per case with a unique UDI code starting with (01)10887709051055.
Look for the lot numbers 4590834, 4557481, 4536601, 4724818, or 4733548 on the packaging.
The internal surface of the NanoClave component may have a manufacturing defect that could inhibit a proper seal with the NanoClave spike.
Check for the specific lot numbers: 4590834, 4557481, 4536601, 4724818, or 4733548. The product comes in 50 pouches per case with a unique UDI code starting with (01)10887709051055.
The recall does not specify a stop-use instruction; the hazard is described as a potential seal failure risk, which is considered low risk.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0187-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0187-2021 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.
