ICU Medical recalls blood sets with potential spinning Luer leaks causing delays, contamination, or blood exposure. Affected models include Spiros with REF: Z2795.
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 blood sets that may leak due to a molding defect. This could delay infusions, contaminate fluids, or expose patients to blood or medications.
A molding defect causes spinning male Luer fittings to leak. This leakage might delay fluid delivery, contaminate the fluid path, or expose patients to blood or medications.
Healthcare workers using these blood sets for patient care are most at risk. Patients receiving blood transfusions with these sets could face contamination or exposure.
Check for the model name 'Spiros' with reference number Z2795. These sets were sold in specific lots: 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, 4909635.
Look for lot numbers 4758192, 4763891, 4794293, 4807842, 4849283, 4866670, 4877784, 4902534, or 4909635 on the blood set.
A molding defect causes spinning male Luer fittings to leak, potentially delaying infusions or causing contamination.
Check for the model name 'Spiros' with reference number Z2795 and lot numbers from the list provided.
The recall 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-0711-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0711-2021 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.
