ICU Medical recalls Sapphire Microbore Infusion Sets with inline filters due to potential fluid leakage from air vents. Affected units sold outside the U.S. with specific product code and lot number.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid can leak from air vents on the filters. This could cause medication to leak out of the patient's IV line, potentially leading to incorrect dosing or infection. The recall applies to specific units sold outside the U: 240119201 product code and lot 916205H.
Fluid can leak from the air vents on the inline filters, which could cause medication to leak out of the patient's IV line. This might lead to incorrect dosing or infection if the leaking fluid enters the patient's bloodstream.
Healthcare professionals using the specific infusion sets for IV administration are affected. Patients receiving IV treatments with these sets are at risk if fluid leaks from the air vents.
Check for the product code 240119201 and lot number 916205H on the packaging. These units were sold outside the U.S. and are part of the Sapphire Microbore Infusion Sets with inline filters.
Look for the product code 240119201 and lot number 916205H on the packaging to confirm if your unit is affected.
No, these units were not distributed in the U.S.
Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL.
Check for the product code 240119201 and lot number 916205H on the packaging.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0146-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0146-2020 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.
