ICU Medical recalls certain 35" IV admin sets with a molding defect that may cause leakage when inactivated. Affected units have a red cap and specific lot numbers. Consumers should contact the company for details.
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 specific IV administration sets that may leak fluid due to a molding defect. This could lead to improper fluid delivery to patients, posing a risk during medical use.
The molding defect in the IV set may cause small amounts of fluid to leak when the device is in the 'inactivated' position. This leakage could lead to improper fluid delivery to patients during medical procedures.
Healthcare professionals using the recalled IV sets for patient fluid administration are most at risk. Patients receiving treatment with these sets could experience complications from potential leakage.
Check for the red cap on the set. The specific lot number 5135759 is associated with this recall. The product was sold with a 35-inch (89 cm) length and 3.9 ml capacity.
Reach out to ICU Medical directly for specific instructions on how to handle the recalled product.
The recall indicates a potential leakage risk due to a molding defect, so it is not safe to use without contacting the manufacturer.
The lot number for this recall is 5135759.
Look for the red cap on the set and check the lot number 5135759.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1589-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1589-2021 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.
