Smiths Medical recalls high pressure rotators with male luer lock (lot 4332915, 4408772) due to potential medication leaks from seal defects. Affected users should 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 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-dosing.
Check for the lot numbers 4332915 or 44087: 4408772 on the device. The product is a high-pressure rotator with male luer lock.
Reach out to Smiths Medical ASD, Inc. for instructions on remedy.
The inner diameter of the O-ring may be oversized, affecting seal integrity and potentially causing medication leaks.
Check for lot numbers 4332915 or 4408772 on the device. The product is a high-pressure rotator with male luer lock.
Contact Smiths Medical ASD, Inc. for instructions on remedy.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0743-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0743-2024 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.