Smiths Medical recalls high pressure rotators with female Luer lock (lot 4330826, 4384397) due to potential medication leaks from seal defects. Affected users should check their product 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 specific high-pressure rotators that may leak medication due to a seal defect. This could lead to under-infusion of medication during use.
The O-ring seal in the rotator may be oversized due to a manufacturing defect. This can cause leaks during medication infusion, potentially leading to under-infusion of medication.
Healthcare professionals using the recalled rotators for medication infusion are most at risk. Patients receiving medication through these devices may experience under-infusion if the leak occurs.
Check for the product name 'High Pressure Rotator with Female Luer Lock' and list number MX497HP. The affected lot numbers are 433:0826 and 4384397.
Identify the list number (MX497HP) and lot numbers (4330826, 4384397) to confirm if your device is affected.
The recall is for potential medication leaks that could lead to under-infusion, but the risk is low as the defect affects specific lots.
Check for the list number MX497HP and lot numbers 4330826 or 4384397 on the device label.
The recall does not specify a remedy, so contact Smiths Medical for further 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-0744-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0744-2024 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.
