ICU Medical recalls Sapphire Microbore Infusion Sets with Inline Filters due to potential fluid leakage from air vents. Affected units include specific model codes and lot numbers. Consumers should check their product details and contact the company 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 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 model codes and lot numbers listed in the recall notice.
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 contamination if the leakage affects the infusion process. However, the recall does not indicate a risk of serious injury in normal use.
Patients using the Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented are most at risk. Healthcare providers who use these specific infusion sets may also be affected.
Check for the model code SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch on the product label. Affected units have specific lot numbers (855995H, 865505H, 876185H) and product code 163840455.
Look for the model code SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch on the product label.
The recalled model is SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch.
Check for the model code SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch and lot numbers 855995H, 865505H, or 876185H.
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-0134-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0134-2020 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.
