ICU Medical recalls 154cm intravascular sets with incorrect 1.2 micron filter assembly. This may cause improper fluid delivery during medical procedures. Affected units distributed only in the U.S. with specific model and lot numbers.
Due to the incorrect filter assembly.
ICU Medical is recalling 154 cm intravascular administration sets that have an incorrect filter assembly. This could lead to improper fluid delivery during medical procedures, potentially causing complications for patients receiving treatment.
The recall is due to an incorrect filter assembly in the intravascular administration set. This could lead to improper fluid delivery during medical procedures, potentially causing complications for patients receiving treatment. The specific issue may affect the safety and effectiveness of the fluid administration process.
Healthcare professionals using these sets for intravenous fluid administration in the U.S. are most at risk, as the incorrect filter could cause improper fluid delivery during medical procedures.
Check for the model number 011-H3182 and lot number 4806428 on the product. These sets were distributed only in the U.S. and are single-use medical devices.
Verify the model number (011-H3182) and lot number (4806428) on the product label.
The recall indicates an incorrect filter assembly, which could lead to improper fluid delivery. Do not use the product until you confirm it is not affected.
Check for model number 011-H3182 and lot number 4806428 on the product label. These sets were distributed only in the U.S. as single-use medical devices.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0958-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0958-2021 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.
