Smiths Medical recalls Medex 20IN (50.8cm) infusion adapters with potential leak causing underdose. Affected units have specific lot numbers; contact for remedy.
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 Medex 20IN (50.8cm) infusion adapters that may leak during medication use, leading to underdosing. This defect affects specific production lots and could cause medication not to be delivered properly.
The O-ring in the adapter may be oversized, causing a leak during medication infusion. This leak can result in medication not being delivered in the correct amount, potentially leading to underdosing.
Users of Medex 20IN infusion adapters with specific lot numbers (4398433) are affected. Healthcare professionals and patients using these adapters for medication delivery are at risk of underdosing.
Check for the lot number 4398433 on the Medex 20IN (50.8cm) infusion adapter. The product is sold under list number MX682R by Smiths Medical ASD, Inc.
Look for the lot number 4398433 on the Medex 20IN (50.8cm) infusion adapter.
The recall involves a potential leak that could cause underdosing, but the hazard level is low risk as it does not cause immediate serious injury.
Check for the lot number 4398433 on the Medex 20IN (50.8cm) infusion adapter.
The recall record does not specify a remedy, so contact Smiths Medical for further instructions.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0746-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0746-2024 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.
