ICU Medical recalls certain 45" smallbore extension sets with a potential leakage risk from molding defects. Affected units may leak fluid when not in use, requiring immediate action.
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 specific smallbore extension sets that could leak fluid when not in use due to a molding defect. This poses a risk of fluid leakage during medical procedures, which could affect patient safety.
The molding defect causes small amounts of fluid leakage when the set is in the inactivated position. This leakage could occur during medical procedures, potentially affecting patient safety.
Patients using these medical sets for fluid administration are at risk. Healthcare providers using the affected models should check their inventory.
Check for the model number REF CL41: 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set with Spiros w/Red Cap. The lot number 5142912 is associated with this recall.
Verify the model number and lot number to confirm if your set is affected.
The recall indicates a potential for small fluid leakage due to a molding defect, but it is not described as causing serious injury.
Check for the model number REF CL4151 and lot number 5142912 on the product label.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1575-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1575-2021 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.
