ICU Medical recalls 30" admin sets with potential leakage due to molding defects. Affected units may leak fluid when inactivated. Consumers should contact for details.
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 a specific type of IV administration set because a molding defect might cause small leaks when the device is in the 'inactivated' position. This could lead to fluid leakage during medical use, which may pose a risk to patients.
The molding defect can cause small amounts of fluid to leak when the device is in the 'inactivated' position. This leakage could potentially lead to fluid loss or contamination during medical procedures.
Patients receiving IV treatments using this specific admin set are most at risk. Healthcare providers using the recalled model for fluid administration may also be affected.
Check for the model number REF CL3028T on the product. The specific lot number 5125199 is affected. This product includes a 30" (76 cm) tube with a 0.2 micron filter and chemo lock drip chamber.
Reach out to ICU Medical for specific instructions on how to verify if your product is affected.
The recall indicates a potential leakage risk due to a molding defect, so it is not recommended for use until the manufacturer provides instructions.
Contact ICU Medical directly to determine if your specific unit is affected and to receive further instructions.
Check for the model number REF CL3028T and the specific lot number 5125199 on the product label.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1571-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1571-2021 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.
