ICU Medical recalls 25 units of Spiros closed male luer with red cap due to molding defect causing potential fluid leaks. Leaks may delay infusions, cause contamination or exposure risks. Affected units have specific model numbers and serial 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 25 units of Spiros closed male luer connectors with red caps because a molding defect can cause fluid leaks. These leaks might delay medical infusions, contaminate the fluid path, or expose patients to hazardous medications or blood.
A molding defect in the Spiros closed male luer connector can cause spinning versions to leak fluid. This leakage might delay medication infusions, contaminate the fluid path, expose patients to hazardous medications, cause blood loss, or introduce air into the fluid line.
Healthcare professionals using these specific medical connectors for IV administration are most at risk. Patients receiving treatments through these devices could face exposure risks if leaks occur.
Check for Spiros closed male luer connectors with red caps (model REF: 011-CH2000SC-25) sold in 25-unit sets. Affected units have specific model numbers and serial lots listed in the recall notice.
Identify if your Spiros closed male luer connector has a red cap and model number REF: 011-CH2000SC-25.
25 units of Spiros closed male luer connectors with red caps (model REF: 011-CH2000SC-25).
A molding defect that can cause spinning versions of the male luer to leak fluid.
Fluid leaks may delay infusions, contaminate the fluid path, expose patients to hazardous medications, cause blood loss, or introduce air into the fluid line.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0706-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0706-2021 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.
