ICU Medical recalls specific IV sets with potential spinning luer leaks causing fluid contamination, exposure to hazardous medications, or blood loss. Affected models include CL3011 and others listed in the recall notice.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
ICU Medical is recalling certain IV sets that may leak due to a molding defect in the spinning luer connection. This could lead to delays in medication delivery, contamination of fluids, exposure to hazardous drugs, or blood loss for patients.
The molding defect in the spinning luer connection can cause leaks when the IV set spins. This may lead to fluid leakage, which could delay medication delivery, contaminate the fluid path, expose patients to hazardous medications, cause blood loss, or introduce air into the fluid line.
Healthcare professionals and patients using the recalled IV sets are most at risk, particularly those receiving chemotherapy or other intravenous treatments where precise fluid delivery is critical.
Check for the product model numbers listed in the recall: CL3011, CL3011T, CL3020, CL3028, CL3028T, CL3361, CL3538, CL3929, CL3931, CL3932, CL3935, CL3941, CL3946, CL3948, CL3960, CL3960T, CL4100, CL4131, CL4151, CL3978. These sets are sold with specific lengths and features.
Immediately stop using any IV sets with the model numbers listed in the recall notice to prevent potential leaks and contamination.
The affected sets include models CL3011, CL3011T, CL3020, CL3028, CL3028T, CL3361, CL3538, CL3929, CL3931, CL3932, CL3935, CL3941, CL3946, CL3948, CL3960, CL3960T, CL4100, CL4131, CL4151, and CL3978.
The molding defect can cause leaks when the IV set spins, potentially delaying medication delivery, contaminating fluids, exposing patients to hazardous medications, causing blood loss, or introducing air into the fluid line.
The recall notice does not specify a return process or deadline for returning the affected sets.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0703-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0703-2021 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.
