ICU Medical recalls a specific 30" IV admin set due to potential leakage in the inactivated position from molding defects. Affected units may leak fluid when not in use.
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 30-inch IV admin set because a molding defect could cause small leaks when the device is not spinning. This could lead to fluid leakage during medical use, potentially affecting patient safety.
The molding defect in the admin set can cause small amounts of fluid to leak when the device is in the inactivated position. This leakage could occur during medical use, potentially leading to unintended fluid exposure for patients.
Healthcare professionals using the specific model for patient IV administration are most at risk. Patients receiving IV fluids through this device may be affected if the leakage occurs.
Check for the model number REF CH323: 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set with 15 Micron Filter. The lot number 5125276 is also associated with this recall.
Verify the model number and lot number to confirm if your admin set is affected.
The recall is for a potential leakage risk due to a molding defect, but it is considered low risk as it only involves small amounts of fluid leakage.
Check for the model number REF CH323: 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set with 15 Micron Filter and lot number 5125276.
The recall does not specify a remedy, so you should check the product details to confirm if it's affected and contact ICU Medical for further 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-1588-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1588-2021 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.
