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 can leak from air vents. This could cause medication to leak out of the patient's IV line, potentially leading to incorrect dosing or infection.
Fluid leakage from air vents on the inline filters can cause medication to leak out of the IV line. This may lead to incorrect dosing, patient infection, or other complications if the leakage is not detected.
Healthcare professionals using these infusion sets for IV administration in medical facilities. Patients receiving IV treatment with these specific sets are at risk of medication leakage.
Check for product labels stating 'SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL'. The product was sold outside the U.S. with specific lot numbers: 855755H, 876275H, 905975H.
Look for the label 'SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL' on the infusion set packaging.
No, these units were not distributed in the U.S. as stated in the recall record.
Lot numbers 855755H, 876275H, and 905975H are affected.
Check the product label for 'SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL' and verify the lot numbers listed in the recall.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0142-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0142-2020 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.
