ICU Medical recalls Sapphire Microbore Infusion Sets with inline filters due to potential fluid leakage from air vents. Affected units have specific model and lot numbers. Consumers should check their product details.
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. 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 can leak fluid through the air vents. This leakage might cause medication to flow out of the patient's IV line, leading to incorrect dosing or infection risks.
Patients using IV therapy with these specific infusion sets are most at risk. Healthcare providers who use the recalled sets for medical treatments may also be affected.
Check for the product label: 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch'. Look for lot numbers starting with 896225H, 916845H, 925825H, or 948155H.
Identify the product label and lot numbers to confirm if your unit is affected.
The recall is due to potential fluid leakage from air vents on the inline filters, which could lead to medication leaking out of the IV line.
Check for the label 'SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch' and lot numbers starting with 896225H, 916845H, 925825H, or 948155H.
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-0132-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0132-2020 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.
