ICU Medical recalls 40" admin sets with potential leakage in Spiros male luer due to molding defect. Affected units may leak fluid when not in use. Contact for return instructions.
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 40-inch IV admin sets that could leak fluid when not in use due to a molding defect. This risk could cause contamination or infection if fluid leaks into the patient's bloodstream.
The molding defect causes small amounts of fluid to leak from the Spiros male luer when the set is not in use. This leakage could potentially contaminate the patient's bloodstream if the set is not properly secured.
Patients receiving IV fluids through this admin set are most at risk. Healthcare workers using these sets in medical facilities may also be affected.
Check for the model number REF CH3020 on the admin set. The affected units have a specific lot number: 5125290. These sets are used for administering fluids to patients through veins.
Inspect the Spiros male luer for signs of fluid leakage when the set is not in use.
Reach out to ICU Medical for return instructions or alternative solutions.
The recall indicates a potential for fluid leakage when the set is not in use, which could lead to contamination or infection if fluid enters the bloodstream.
Look for the model number REF CH3020 and lot number 5125290 on the admin set.
The recall does not require immediate discontinuation; however, checking for leakage and contacting the manufacturer for guidance is recommended.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1579-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1579-2021 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.
