ICU Medical recalls a specific transfer set model due to a molding defect that may cause small leakage when inactivated. Affected units have a unique lot number and serial code. 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 a specific transfer set model because a molding defect might cause small leakage when the device is in the inactivated position. This could lead to fluid leakage during medical use, potentially affecting patient safety.
The molding defect in certain lots of the transfer set can cause small amounts of fluid leakage when the device is in the inactivated position. This leakage could potentially lead to unintended fluid administration or contamination during medical procedures.
Patients using this transfer set for fluid administration may be affected. Healthcare professionals who use the device for medical purposes are most at risk.
Check for the lot number 5125225 and the unique serial code (01) 1 0840619 06655 1 (17) 26010: 50 (10) 5125225 on the product. The product is a 42 cm (16.5 in) transfer set with an approximate volume of 2.6ml.
Reach out to ICU Medical directly for specific instructions on how to verify if your product is affected and what to do next.
The product is a 42 cm (16.5 in) transfer set with an approximate volume of 2.6ml, Clave ADDITIVE PORT, BCV, and Spiros.
Check for the lot number 5125225 and the unique serial code (01) 1 0840619 06655 1 (17) 26010: 50 (10) 5125225 on the product.
Contact ICU Medical directly for specific instructions on how to verify if your product is affected and what to do next.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1583-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1583-2021 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.
