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. Consumers should check their units for the listed identifiers.
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 on the inline filters. This could lead to improper medication delivery if the leakage affects the infusion process. Affected units have specific product codes and lot numbers.
Fluid leakage from air vents on the inline filters could cause medication to leak out of the system. This might lead to incorrect dosing or incomplete treatment if the leakage affects the infusion process.
Patients using IV infusion pumps with the recalled Sapphire Microbore Infusion Sets are most at risk. Healthcare providers who use these specific sets for medical treatments may also be affected.
Check for the product code 240100401 and lot numbers starting with 897525H, 905915H, or 926235H. The sets are labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch.
Identify the product code (240100401) and lot numbers (897525H, 905915H, 926235H) to confirm if your set is affected.
The recalled sets are Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch.
Check for product code 240100401 and lot numbers starting with 897525H, 905915H, or 926235H.
The recall record does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0135-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0135-2020 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.
