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. Stop using immediately to prevent injury.
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 out of air vents. This could cause medication to leak into the patient's airway, leading to serious health risks. Affected units have specific product codes and lot numbers.
Fluid leakage from air vents in the inline filters could cause medication to enter the patient's airway instead of the bloodstream. This might lead to serious health issues or injury if the leakage occurs during treatment.
Patients using these infusion sets for medical treatment are at risk. Healthcare providers who use the recalled sets should stop using them immediately.
Check for product codes starting with 163830455 and lot numbers like 855665H, 865495H, 896195H, 3849197, or 4064964. The sets are labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch.
Discard the recalled infusion sets to prevent fluid leakage that could cause medication to enter the patient's airway.
Sapphire Microbore Infusion Sets with inline filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch.
Check for product code 163830455 and lot numbers 855665H, 865495H, 896195H, 3849197, or 4064964.
Discard the product immediately to prevent fluid leakage that could cause medication to enter the patient's airway.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0133-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0133-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
