ICU Medical recalls syringes with spinning Spiros and red caps due to a molding defect that may cause fluid leaks, risking infusion delays, contamination, or exposure to hazardous medications.
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 syringes with spinning Spiros and red caps (3mL, 5mL, 10mL) because a molding defect may cause fluid leaks. This could lead to infusion delays, contamination, or exposure to hazardous medications during medical use.
A molding defect in the syringes can cause spinning male luers to leak fluid. This leakage may delay infusions, contaminate the fluid path, expose patients to hazardous medications, cause blood loss, or introduce air into the fluid line.
Healthcare professionals using these syringes for medical treatments are most at risk. Patients receiving infusions with these syringes could face contamination or exposure to hazardous medications.
Check for syringes with a red cap and 'Spinning Spiros' label. The product codes (REFs) listed in the recall include CH2003, CH2005, CH2010, CH2020, CH2030, CH2060, and others. These were sold with specific sizes and accessories.
Identify if your syringes have a red cap and 'Spinning Spiros' label with the listed REF codes (e.g., CH2003, CH2005).
Reach out to ICU Medical directly for guidance on whether your syringes are affected and what steps to take.
The recall states that these syringes may leak due to a molding defect, so they are not safe for medical use without addressing the issue.
Contact ICU Medical to determine if your syringes are affected and follow their instructions.
The recall mentions potential risks like contamination, exposure to hazardous medications, or blood loss, but does not specify if serious injury is likely in normal use.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0704-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0704-2021 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.
