ICU Medical recalls Spinning Spiros and SURPLUG ChemoAccess Luer fittings with 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 Spinning Spiros and SURPLUG ChemoAccess Luer fittings due to a molding defect that can cause leaks. This may lead to infusion delays, contamination, exposure to hazardous medications, or blood loss in medical use.
A molding defect in the Luer fittings can cause leaks during use. Leaks may delay medication infusions, contaminate the fluid path, expose patients to hazardous medications, or cause blood loss.
Healthcare professionals using these medical fittings for IV infusions are most at risk. Patients receiving treatments through these fittings could face contamination or exposure if leaks occur.
Check for Spinning Spiros or SURPLUG ChemoAccess fittings with model numbers 060-CH2000S or 066-CH2000S. These were sold in specific lots listed in the recall notice.
Inspect the fittings for signs of fluid leakage, which could indicate the molding defect.
Reach out to ICU Medical for guidance on next steps if leaks are found.
A molding defect in the Luer fittings can cause leaks, potentially delaying infusions, contaminating fluid paths, or exposing patients to hazardous medications.
Spinning Spiros with REF: 060-CH2000S and SURPLUG ChemoAccess with REF: 066-CH2000S, sold in specific lots listed in the recall notice.
Look for model numbers 060-CH2000S or 066-CH2000S on the fittings, and check the specific lots listed in the recall notice.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0700-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0700-2021 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.