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 codes.
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 may leak from air vents. This could cause medication to leak into the patient's airway, posing a serious risk during IV administration.
Fluid leakage from air vents on the inline filters could allow medication to flow into the patient's airway instead of the bloodstream. This may cause serious injury or death if the leakage occurs during IV treatment.
Healthcare professionals using these infusion sets for IV administration are most at risk. Patients receiving IV treatments with the recalled sets could face medication leakage.
Check for the product label 'SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL'. The product code is 163353155 with lot numbers 885685H or 3959757. These sets were not distributed in the U.S.
Immediately stop using the recalled infusion sets as they may leak medication into the patient's airway.
No, these sets were not distributed in the U.S. and are only available outside the country.
The product code is 163353155 with lot numbers 885685H or 3959757.
Look for the label 'SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL' 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-0140-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0140-2020 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.
