ICU Medical recalls certain Sprios male luer sets that may leak fluid due to a molding defect. Affected units were sold with specific lot numbers and model identifiers. Consumers should contact the company for details on the recall.
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 Sprios male luer sets that could leak fluid due to a molding defect. This defect might cause small amounts of fluid to leak when the device is in the inactivated position, potentially affecting patient safety during medical use.
A molding defect in certain Sprios male luer sets can cause small amounts of fluid to leak when the device is in the inactivated position. This leakage could potentially affect patient safety during medical fluid administration.
Patients using these Sprios male luer sets for medical fluid administration are most at risk. The recall affects specific lot numbers and model identifiers sold with the product.
Check for the lot number 5142887 and model identifiers including REF 011-H2864-HSR. The product is used for administering fluids to patients through a vein.
Reach out to ICU Medical for specific recall details and instructions.
Due to a molding defect, certain lots of Sprios male luer sets may leak fluid when in the inactivated position.
The affected model is REF 011-H2864-HSR with lot number 5142887.
Check for the lot number 5142887 and model identifiers including REF 011-H2864-HSR.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1582-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1582-2021 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.
