ICU Medical recalls 30" admin sets with potential leakage in Sprios male luer due to molding defect. Affected units may leak fluid when inactivated. Contact for remedy.
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 30-inch IV admin sets that may leak fluid when in the 'inactivated' position due to a molding defect. This could cause fluid leakage during medical use, potentially affecting patient safety.
The molding defect causes small amounts of fluid to leak from the Sprios male l.uer when it's in the 'inactivated' position. This leakage could happen during medical use, potentially leading to fluid loss or contamination.
Healthcare professionals using the recalled admin sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could be affected if leakage occurs.
Check for the model number REF CL3011 on the admin set. The affected units have a red cap and are sold with a hanger. The lot number 5125298 is associated with this recall.
Inspect the Sprios male luer for small amounts of fluid leakage when in the 'inactivated' position.
The recall indicates a potential for small fluid leakage due to a molding defect, but it's not described as causing serious injury. The risk is low.
Look for the model number REF CL3011 on the admin set, which has a red cap and hanger. The lot number 5125298 is associated with this recall.
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-1570-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1570-2021 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.
