Smiths Medical recalls specific 20-inch infusion lines due to potential medication underdose from leaks caused by a manufacturing defect in the 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 certain 20-inch infusion lines that may leak medication due to a defective O-ring seal. This could lead to under-infusion of medication, which is a serious risk for patients using these devices.
The O-ring seal in the infusion line may be oversized due to a manufacturing defect. This can cause leaks during medication infusion, potentially leading to underdosing of medication.
Patients using the recalled infusion lines for medication delivery are at risk. Healthcare providers who use these devices for medical treatments may need to take extra care.
Check for the product name '20IN (50.8CM) BRAIDED INJ LINE, ROTATING AD: List Number MX682BR' and lot numbers 4398428 or 4404690.
Identify the product by checking the list number MX682BR and lot numbers 4398428 or 4404690.
The recall is due to a manufacturing defect that may cause the O-ring seal to be oversized, leading to potential medication leaks and underdosing.
Look for the product name '20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT' with list number MX682BR and lot numbers 4398428 or 4404690.
The recall record does not specify a remedy, so contact Smiths Medical for guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0745-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0745-2024 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.
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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.
