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 Microb: 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.
The inline filters on these infusion sets have air vents that can leak fluid. This leakage might cause medication to escape the IV line, leading to incorrect dosing or infection risks for patients.
Healthcare professionals using these infusion sets for patient IV administration are most at risk. Patients receiving IV treatment with the recalled sets could be affected if the leakage occurs.
Check for the product label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL'. The product code is 163633155 and lot numbers 937585H or 3959758. These sets were not distributed in the U.S.
Look for the label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL' on the infusion set.
No, these sets were not distributed in the U.S. according to the recall record.
The product code is 163633155.
Check for the label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL' and product code 163633155 with lot numbers 937585H or 3959758.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0143-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0143-2020 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.
