ICU Medical recalls 124" burette sets with possible seal failure due to manufacturing defect. Affected units may not seal properly with NanoClave spikes. Consumers should contact for remedy 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 124-inch burette sets that may have a manufacturing defect causing improper sealing with NanoClave spikes. This could lead to fluid leaks during medical use, potentially causing injury.
The burette set's NanoClave component may have a manufacturing defect that prevents it from sealing correctly with the NanoClave spike. This could cause fluid leaks during intravenous administration, potentially leading to patient injury.
Healthcare professionals using the burette sets for intravenous fluid administration are most at risk. Patients receiving IV treatments with these sets could face fluid leaks.
Check for the lot number 4719728 on the product packaging. The affected sets are 124-inch (315 cm) burette sets with specific components including 2 Gang Clave Stopcocks and 2 Clave.
ICU Medical will provide remedy details for affected units with lot number 4719728.
The internal surface of the NanoClave component may have a manufacturing defect that inhibits proper sealing with the NanoClave spike.
Check for the lot number 4719728 on the product packaging. The affected sets are 124-inch (315 cm) burette sets with specific components including 2 Gang Clave Stopcocks and 2 Clave.
Contact ICU Medical for remedy details as the recall does not specify a stop-use action.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0260-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0260-2021 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.
