ICU Medical recalls 50-pouch sets with potential manufacturing defect causing improper seal with NanoClave spikes. Affected units have specific lot number 4572792. Consumers should contact manufacturer for details.
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 small medical tubing sets that may not seal properly with their spikes due to a manufacturing defect. This could lead to improper fluid delivery 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 leakage or improper delivery during medical procedures.
Healthcare professionals using these sets for medical fluid delivery, particularly those in hospitals or clinics. Patients receiving treatments through these sets are at risk if the seal fails.
Look for the specific lot number 4572792 on the packaging. The product is a 6.5" (17 cm) small-bore pressure infusion set with a purple NanoClave clamp, sold in 50-pouch cases.
Verify the lot number on the packaging to confirm if your set is affected (lot 4572792).
Reach out to ICU Medical for specific instructions on how to handle affected units.
The affected lot number is 4572792.
Check for the lot number 4572792 on the packaging. The product is a 6.5" (17 cm) small-bore pressure infusion set with a purple NanoClave clamp.
Contact ICU Medical for specific instructions on handling affected units.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0204-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0204-2021 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.
