ICU Medical recalls Sapphire Microbore Infusion Sets with Inline Filters due to potential fluid leakage from air vents. Affected units have specific product codes and lot numbers. Contact for replacement.
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 out of air vents on the inline filters. This could lead to improper medication delivery if the leakage affects the infusion process.
The inline filters on these infusion sets may allow fluid to leak out of the air vents. This could cause medication to be delivered incorrectly or not at all, potentially affecting patient treatment.
Healthcare professionals using these specific infusion sets for patient care are most at risk. Patients receiving IV treatments with the recalled sets could be affected if fluid leakage occurs.
Check for the product label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch'. Look for product code 163630455 and lot numbers listed in the recall notice.
Look for the label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch' on the infusion set.
Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch.
Check for the product code 163630455 and lot numbers listed in the recall notice, including 876175H, 885385H, 896995H, 908235H, 925755H, and 3843264.
The recall does not specify a remedy, so contact ICU Medical directly for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0131-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0131-2020 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.
