Smiths Medical recalls 48-inch inject line rotating adapters with potential medication leaks due to O-ring seal defects. Affected units have specific lot numbers; stop using if you have the product.
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 certain 48-inch inject line rotating adapters because a manufacturing defect may cause medication leaks during use. This could lead to under-infusion of medication, which is a serious risk for patients.
The O-ring seal in the adapter may be oversized due to a manufacturing defect. This can cause leaks during medication infusion, potentially leading to under-infusion of medication and treatment complications.
Patients using the recalled adapters for medication infusion are most at risk. Healthcare providers who use these devices in clinical settings may also be affected.
Check for the product name '48IN (121.9CM) INJ LINE ROTATING ADAPT (9:00psi)' with lot numbers 4383431, 4387987, or 4404698. The product was sold with list number MX694R.
Identify the lot number on your adapter to see if it matches 4383431, 4387987, or 4404698.
If your adapter has a recalled lot number, stop using it immediately to prevent medication leaks.
The recall is due to a manufacturing defect that may cause the O-ring seal to be oversized, leading to medication leaks during infusion.
If your adapter has a lot number of 4383431, 4387987, or 4404698, stop using it immediately and contact Smiths Medical for further instructions.
The recall states that under-infusion of medication could occur, which may lead to treatment complications, but 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-0747-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0747-2024 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.
