ICU Medical recalls 30" admin sets with potential leakage from molding defects. Affected units may leak fluid when inactivated. Stop using immediately if you own the specific model.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
ICU Medical is recalling a specific type of IV administration set due to a molding defect that could cause small leaks when the device is inactivated. This defect poses a risk of fluid leakage during medical use, which could lead to patient complications if not addressed.
The molding defect in the admin set can cause small amounts of fluid to leak when the device is inactivated. This leakage could potentially lead to complications during medical treatment if the leak occurs while the device is connected to a patient.
Patients receiving IV treatments using this specific admin set are at risk. Healthcare providers who use the recalled model for fluid administration may need to switch to a different product.
Check for the model name 'REF CH3011 30" (76 cm) Appx 3.3 mL, :20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag'. The lot number 5125297 is also associated with this recall.
If you have the recalled admin set, stop using it right away to prevent potential fluid leakage.
Due to a molding defect that can cause small amounts of fluid leakage when the device is inactivated.
Stop using it immediately and contact ICU Medical for further instructions.
Yes, the lot number 5125297 is associated with this recall.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1578-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1578-2021 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.
