ICU Medical recalls Distale 203 cm Bifuse Ext Sets with specific NanoClave sets due to potential manufacturing defect causing seal failure. Affected units have lot numbers 4537216 or 4726595.
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 Distale 203 cm Bifuse Ext Sets with specific NanoClave sets because a manufacturing defect may prevent proper sealing with the NanoClave spike. This could lead to improper fluid administration during medical procedures.
A manufacturing defect on the internal surface of the NanoClave may prevent it from sealing properly with the NanoClave spike. This could lead to improper fluid administration during medical procedures, potentially causing complications for patients.
Healthcare professionals using these specific Distale sets for patient fluid administration are most at risk. Patients receiving treatments through these sets could be affected if the seal fails.
Check for Distale 203 cm Bifuse Ext Sets with NanoClave sets having lot numbers 4537216 or 4726595. These sets come in 20 pouches per case and are single-use medical devices.
Look for lot numbers 4537216 or 4726595 on the packaging or device.
The recall states a potential manufacturing defect on the internal surface of the NanoClave that may inhibit a proper seal with the NanoClave spike.
Check for Distale 203 cm Bifuse Ext Sets with NanoClave sets having lot numbers 4537216 or 4726595.
The recall does not specify a stop-use instruction; the remedy is null, so users should check if they have the affected lot numbers.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0271-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0271-2021 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.
