ICU Medical recalls specific admin sets for potential small leakage when inactivated. Affected units may leak fluid during use, risking infection. Contact for return instructions.
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 admin sets that could leak small amounts of fluid when inactivated. This leakage might increase infection risk during medical procedures.
The molding defect causes small leaks in the inactivated position of certain Spinos male luer components. This leakage could introduce contaminants into the patient's bloodstream during fluid administration.
Healthcare professionals using the recalled admin sets for patient fluid administration. Patients receiving treatment with these sets are at risk of potential infection from leaks.
Check for the lot number 5125174 on the admin set packaging. The product is labeled as REF 011-CH3967 with UDI code (01) 1 0887709 12205 2.
Inspect the admin set for small leaks when inactivated. If leaks are present, stop using it immediately.
The recall indicates a potential for small leaks during inactivation, which could increase infection risk. However, the hazard level is low risk as the leaks are small and not immediately dangerous.
Look for the lot number 5125174 on the admin set packaging. The product is labeled as REF 011-CH3967 with UDI code (01) 1 0887709 12205 2.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on handling the product.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1581-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1581-2021 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.
