ICU Medical recalls 60mL syringes with spinning Spiros male luer fittings due to a molding defect that may cause small leakage when inactivated. Affected units have specific lot numbers and red caps.
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 60mL syringes with spinning Spiros male luer fittings because a molding defect may cause small leakage when the syringe is inactivated. This could lead to fluid leakage during medical administration, potentially causing contamination or inaccurate dosing.
A molding defect in the syringe's spinning Spiros male luer fittings can cause small amounts of fluid leakage when the syringe is inactivated. This leakage could lead to inaccurate dosing or contamination during medical fluid administration.
Healthcare professionals and patients using the recalled syringes for fluid administration. Those with the specific lot number 5125260 and red cap are most at risk.
Check for the red cap on the syringe. Affected units have the lot number 512:5260 and were sold with the product code REF CH2060.
Look for the red cap on the syringe to identify if it is part of the recalled model.
Confirm the lot number is 5125260 to determine if the syringe is affected.
The recall is due to a molding defect that may cause small leakage when the syringe is inactivated, potentially leading to inaccurate dosing or contamination during medical fluid administration.
Check for the red cap and verify the lot number is 5125260. The affected syringes have the product code REF CH2060.
The recall does not specify a remedy, so contact ICU Medical directly for guidance on next steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1577-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1577-2021 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.