ICU Medical recalls specific IV sets that may leak fluids, risking infusion delays, contamination, or exposure to medications. Affected models include Spinning Spiros with red or purple caps.
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 could leak fluids due to a molding defect. This might delay treatments, cause contamination, or expose patients to medications or blood.
A defect in the molding can cause spinning versions of male luers to leak fluid. This leakage might delay medication delivery, contaminate the fluid path, or expose patients to hazardous medications or blood.
Patients using these IV sets for medical treatments are most at risk. Healthcare providers and facilities that use the recalled models should check their inventory.
Check for models with red or purple caps labeled as Spinning Spiros Closed Male Luer. The product codes include references like CH2000S, CH2000SC, CH3515, or Z7072. These were sold with specific lot numbers listed in the recall.
Look for the model name and cap color (red or purple) on the IV set. The product codes include references like CH2000S, CH2000SC, or Z7072.
Reach out to ICU Medical directly for confirmation of the recalled model and instructions on next steps.
A molding defect in the spinning versions of male luers can cause fluid leaks, which might delay treatments, contaminate the fluid path, or expose patients to medications or blood.
Affected models include Spinning Spiros Closed Male Luer with red or purple caps, identified by product codes like CH2000S, CH2000SC, CH3515, or Z7072, and specific lot numbers listed in the recall.
No immediate stop is required, but you should check if your IV set is affected and contact ICU Medical for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0702-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0702-2021 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.
