Smiths Medical recalls specific 105:0 STOPCOCK left rotator handles due to potential medication leaks from seal defects. Affected units have Lot Number 4387166. 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 certain 1050 STOPCOCK left rotator handles 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 device 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 1050 STOPCOCK left rotator handles with Lot Number 4387166 are most at risk. Patients receiving medication through this device could experience under-infusion.
Check for Lot Number 4387166 on the 1050 STOPCOCK left rotator handle. The product was sold with List Number MX1431MRL.
Look for Lot Number 4387166 on the 1050 STOPCOCK left rotator handle.
The O-ring seal may be oversized due to a manufacturing defect, affecting seal integrity.
An inadequate seal may cause leaks during infusion, potentially leading to under-infusion of medication.
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-0740-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0740-2024 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.