ICU Medical recalls specific Sprios male luer sets (lot 5125197) due to a molding defect that may cause small leakage in the inactivated position. Affected units are for cytotoxic medication administration.
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 a specific lot of Sprios male luer sets (lot : 5125197) because a molding defect could cause small leakage when the device is in the inactivated position. This is a safety concern for patients receiving cytotoxic medications.
A molding defect in the Sprios male luer sets can cause small amounts of leakage when the device is in the inactivated position. This leakage could potentially expose patients to medication during administration if the device is not properly sealed.
Healthcare professionals using the Sprios male luer sets for cytotoxic medication administration are most at risk. The recall applies to specific units sold with lot number 5125197.
Check for the lot number 5125197 on the product label. The product is a Sprios male luer set used for cytotoxic medication administration.
Look for the lot number 5125197 on the product label to confirm if it is affected.
The recalled product is ICU Medical's Sprios male luer set with lot number 5125197, used for cytotoxic medication administration.
Due to a molding defect, certain lots of Sprios male luer sets may exhibit small leakage in the inactivated position.
Check the product label for the lot number 5125197. The product is used for cytotoxic medication administration.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1566-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1566-2021 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.
