Smiths Medical recalls Medex Logical Cath Lab Kit (Lot 4371054) due to potential medication underdose from a defective O-ring seal. Affected users should contact the manufacturer for details.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Smiths Medical is recalling a specific batch of Medex Logical Cath Lab Kits because a manufacturing defect may cause leaks during medication infusion, leading to underdosing. This could result in ineffective treatment if the kit is used without the defect being fixed.
The O-ring seal in the kit may be oversized due to a manufacturing defect. This can cause leaks during medication infusion, potentially leading to underdosing of medication. Underdosing could result in ineffective treatment for patients.
Healthcare professionals using the Medex Logical Cath Lab Kit in medical settings are most at risk. Patients receiving medication through this kit could be affected if the defect causes underdosing.
Check for the Lot Number 4371054 on the Medex Logical Cath Lab Kit. The product was sold with UDI-DI: 10351688510686.
Reach out to Smiths Medical ASD, Inc. for specific instructions on how to address the issue with the recalled kit.
The recall applies to specific lots, including Lot Number 4371054. Check your kit's lot number to see if it's affected.
Contact Smiths Medical ASD, Inc. for guidance on how to handle the recalled kit.
The recall states that underdosing could occur, which might lead to ineffective treatment. However, the record does not specify a risk of serious injury.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0739-2024 from Smiths 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
