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 remedy.
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, posing a risk of serious injury.
Fluid leakage from air vents on the inline filters could allow medication to flow into the patient's airway instead of the bloodstream. This may cause serious injury or harm to the patient.
Healthcare professionals using these infusion sets for patient care. Patients receiving IV treatments with the recalled sets are at risk of medication leakage.
Check for product codes 163620455 and lot numbers starting with 855645H, 885415H, 896625H, or 4008547. These sets were sold in pouches with specific labeling.
Identify the product code and lot number on the packaging to confirm if your set is affected.
The recall is due to potential fluid leakage from air vents on inline filters, which could cause medication to leak into the patient's airway.
Check for product code 163620455 and lot numbers starting with 855645H, 885415H, 896625H, or 4008547.
The recall 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-0130-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0130-2020 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.
