ICU Medical recalls specific IV admin sets due to potential leaks from spinning male luers causing infusion delays, contamination, or blood exposure risks.
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 administration sets because a molding defect may cause spinning male luers to leak. This could delay medication delivery, contaminate fluids, or expose patients to blood or hazardous medications.
A molding defect in the male luer fittings may cause leaks when the sets spin. This leakage risks delaying medication delivery, contaminating the fluid path, exposing patients to hazardous medications, blood loss, or air entering the fluid line.
Healthcare professionals using the recalled IV sets for patient care are most at risk. Patients receiving treatments through these sets could face delays or contamination.
Check for the product names and reference numbers listed: 011-CH3261, 011-CH3568, 011-CH3600, 011-CH3601, 011-CH3610, 011-CH3772, 011-CH3773, 011-CH3967, 011-CH4011. These sets were sold in specific lots.
Identify the reference number on the set to confirm if it's recalled.
Reach out to ICU Medical for further instructions on safe handling or replacement.
A molding defect in the male luer fittings may cause leaks when the sets spin, potentially delaying medication delivery, contaminating fluids, or exposing patients to blood or hazardous medications.
Check the reference number on the set to see if it's recalled. Contact ICU Medical for instructions on safe handling or replacement.
Yes, patients receiving treatments through these sets could face delays in medication delivery, contamination of fluids, or exposure to blood or hazardous medications.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0708-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0708-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
