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 contact the company for 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 that may leak fluid from air vents. This could cause medication to leak out of the system, potentially leading to incorrect dosing or infection risks.
Fluid can leak out of the air vents on the inline filters, which could cause medication to leak from the system. This might lead to incorrect dosing or infection risks if the leakage is not noticed.
Patients using these infusion sets for medical treatments are most at risk. Healthcare providers who administer these sets may also be affected.
Check for product codes starting with 163350455 and lot numbers like 855935H, 855965H, 876145H, 885395H, 896135H, 936605H, 3843263, or 3864786. These units were sold in specific packaging with the label 'SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch'.
Look for product codes starting with 163350455 and lot numbers listed in the recall notice.
Reach out to ICU Medical for specific instructions on how to handle the affected units.
The recalled model is Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch.
Check for product codes starting with 163350455 and lot numbers like 855935H, 855965H, 876145H, 885395H, 896135H, 936605H, 3843263, or 3864786.
Contact ICU Medical for specific instructions on how to handle the affected units.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0129-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0129-2020 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.
