ICU Medical recalls Spiros Closed Male Luer due to molding defect causing potential leakage in inactivated position. Affected lots may leak fluids during medical 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 Spiros Closed Male Luer connectors because a molding defect might cause small leaks when the device is inactivated. This could lead to fluid leakage during medical treatments, potentially affecting patient safety.
A molding defect in the Spi: 1) causes small amounts of leakage when the device is inactivated, 2) could lead to fluid leakage during medical administration, 3) potentially affecting patient safety by introducing contaminants or causing fluid loss.
Healthcare professionals using the Spiros Closed Male Luer for fluid administration in medical settings are most at risk. Patients receiving treatments through this device may be affected if leaks occur.
Check for the lot number 5141416 on the device. The product is used for administering fluids from a container to a patient's vascular system through a needle or catheter.
Look for the lot number 5141416 on the Spiros Closed Male Luer connector.
The recall states there is a potential for small leakage due to a molding defect, but it does not indicate a risk of serious injury or death.
The recall does not specify any action steps beyond checking the lot number. If you have the lot number 5141416, you should contact ICU Medical for further instructions.
The recalled product has the lot number 5141416 and is used for administering fluids from a container to a patient's vascular system through a needle or catheter.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1585-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1585-2021 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.
