ICU Medical recalls certain Spinning Spiros Male Luers due to potential leakage in the inactivated position. This could cause fluid leakage during medical use. Affected units have specific lot numbers.
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 Spinning Spiros Male Luers that may leak small amounts of fluid when not in use. This could lead to unintended fluid exposure during medical procedures, though the risk is low.
The device has a molding defect that causes small leaks when not in use. This could result in unintended fluid exposure during medical procedures, potentially causing minor contamination or discomfort.
Healthcare professionals using these medical devices for fluid administration are most at risk. Patients receiving fluids through these devices may be exposed to small leaks.
Check for lot numbers 5135765 or 5142935 on the device. These are the specific units affected by the recall.
Look for lot numbers 5135765 or 5142935 on the device to confirm if it is affected.
The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position.
Check the lot number on the device. If it is 5135765 or 5142935, contact ICU Medical for further instructions.
The recall states a potential for small leakage, but no serious injury risk is mentioned. The danger level is low risk.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1590-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1590-2021 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.
