ICU Medical recalls Spinning Spiros Closed Male Luer sets with a molding defect that may cause fluid leaks, risking infusion delays, contamination, or exposure to hazardous medications. Affected units include specific model numbers and lots.
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 Spinning Spiros Closed Male Luer sets due to a molding defect that can cause leaks. This may lead to infusion delays, contamination, or exposure to hazardous medications. Affected units have specific model numbers and production lots.
A molding defect in the Spinning Spiros Luer can cause fluid leaks. Leaks may delay medication infusion, contaminate the fluid path, expose patients to hazardous medications, or cause blood loss and air in the fluid line.
Healthcare professionals using these medical devices for patient care are most at risk. Patients receiving treatments through these devices could face complications if leaks occur.
Check for the model number IB-CH2000SC or IB-CH3034 on the product. Affected units were sold with lots 4605119, 4726277, or 4727007.
Identify the model number and lot number on the Spinning Spiros Closed Male Luer set to confirm if it is affected.
A molding defect can cause fluid leaks, potentially leading to infusion delays, contamination, or exposure to hazardous medications.
Affected models include IB-CH2000SC and IB-CH3034 with lots 4605119, 4726277, and 4727007.
The recall record does not specify a remedy, so contact ICU Medical directly 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-0709-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0709-2021 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.
