ICU Medical recalls 30" admin sets with potential spinning luer leaks causing infusion delays, contamination, or blood exposure. Affected units have specific lot numbers.
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 30-inch IV admin sets that may leak due to a molding defect. This could delay medication delivery, contaminate fluids, or expose patients to blood or hazardous drugs.
A molding defect causes spinning male luer fittings to leak. This may lead to infusion delays, contaminated fluid paths, exposure to hazardous medications, blood loss, or air entering the fluid line.
Healthcare workers using these IV sets for patient care are most at risk. Patients receiving IV treatments with the recalled sets could face delays or contamination.
Check for the 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set with Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, and Bag Hanger. Affected units have lot numbers 4727479 or 4784305.
Inspect the set for spinning luer fittings that leak fluid, which may indicate the molding defect.
The recall is due to a molding defect that can cause spinning male luer fittings to leak, potentially delaying infusions or causing contamination.
The official recall notice does not specify a remedy, so check for leaks and contact ICU Medical for further instructions.
Yes, affected units have lot numbers 4727479 or 4784305.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0705-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0705-2021 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.
