ICU Medical recalls specific smallbore trifuse sets for potential leakage during use. Affected units may leak fluid when not in use, posing a risk of contamination. Consumers should contact the company for details.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
ICU Medical is recalling certain smallbore trifuse sets that may leak fluid when not in use. This could lead to contamination risks for patients. The recall affects specific model numbers and lot numbers.
The recall is due to a molding defect that causes small amounts of leakage in the inactivated position of the spinning and non-spinning Sprios male luers. This leakage could potentially lead to contamination of the fluid administered to patients.
Patients using these medical sets for fluid administration are most at risk. Healthcare providers and patients who have the specific model numbers listed in the recall are affected.
Check for the model number REF CH3625 with 5" (13 cm) length, 0.50 ml capacity, and purple/green rings. The affected units have lot numbers 5135756 or 5141854.
Verify the model number and lot numbers listed in the recall notice to confirm if your set is affected.
The recalled model is REF CH3625 with 5" (13 cm) length, 0.50 ml capacity, and purple/green rings.
Lot numbers 5135756 and 5141854 are affected.
The recall states that affected sets may leak fluid when not in use, but there is no specific test mentioned in the notice.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1580-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1580-2021 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.
