Smiths Medical recalls specific lots of 6-inch pressure tubing due to potential medication underdose from leaks caused by an oversized O-ring seal.
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 specific lots of 6-inch pressure tubing because an oversized O-ring may cause leaks during medication infusion, leading to underdosing. This could affect patients receiving IV treatments.
The O-ring seal may be oversized in specific lots, causing leaks during medication infusion. This could result in underdosing of medication, which might not be immediately life-threatening but could affect treatment effectiveness.
Patients using this tubing for IV medication infusions, particularly those on critical care or long-term treatments. Healthcare providers who use the tubing for medical purposes are most at risk.
Check the lot number on the tubing packaging. The affected lots are 4380614 and 4416451. This tubing was sold under the list number MX20617.
Look for the lot numbers 4380614 or 4416451 on the tubing packaging.
The recall is due to a manufacturing defect where the O-ring seal may be oversized in specific lots, potentially causing leaks during medication infusion and underdosing.
Check the lot number on the packaging. If it matches 4380614 or 4416451, contact Smiths Medical for further instructions.
The recall addresses potential underdosing of medication, which could affect treatment effectiveness but is not described as causing serious injury in normal use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0741-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0741-2024 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.
