ICU Medical recalls certain Spinning Spiros male luers due to potential small fluid leakage when inactivated. Affected units may leak fluid during medical administration, requiring replacement to prevent complications.
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 models of Spinning Spiros male luers that may leak small amounts of fluid when in the inactivated position. This could lead to unintended fluid administration to patients, posing a risk during medical procedures.
The molding defect causes small amounts of fluid to leak when the luer is in the inactivated position. This leakage could result in unintended fluid administration to patients during medical procedures, potentially causing complications.
Healthcare professionals using these male luers for fluid administration to patients are most at risk. Patients receiving fluids through these devices may experience unintended leakage.
Check for the model numbers CH2000S, CH2000S-10, CH2000S-C, CH2000SC-10, CH2000SC-5, CH2005, or the lot numbers 5125299, 5142922, 5125303, 5142969, 5125289, 5142945, or 5125288.
Identify the model number on the device, which may be CH2000S, CH2000S-10, CH2000S-C, CH2000SC-10, CH2000SC-5, or CH2005.
Check the lot number on the device, which may be 5125299, 5142922, 5125303, 5142969, 5125289, 5142945, or 5125288.
The molding defect causes small amounts of fluid to leak when the luer is in the inactivated position.
Check for the model numbers CH2000S, CH2000S-10, CH2000S-C, CH2000SC-10, CH2000SC-5, or CH2005, or the lot numbers 5125299, 5142922, 5125303, 5142969, 5125289, 5142945, or 5125288.
The recall indicates a potential leakage risk, but the remedy is not specified, so there is no immediate stop-use instruction.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1569-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1569-2021 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.
