WOM World Of Medicine AG has recalled approximately 1,700 WOM Tube Sets for Irrigation used in endoscopic surgeries. These single-use devices, distributed by Endoscopy Smith & Nephew Inc., were manufactured with incorrect transponder data on their RFID tags. This defect triggers an "E03 Tube Set Invalid" error message when the device is connected to surgical equipment, which can lead to unexpected delays during medical procedures. Consumers should identify affected units by the reference number T0449-01 and specific lot numbers 4030902 or 4030903.
The incorrect RFID data causes the surgical irrigation system to reject the tube set as invalid, resulting in an error message that prevents the device from functioning. This failure can cause a delay in surgery while staff attempt to troubleshoot or replace the equipment, potentially increasing the time a patient is under anesthesia or prolonging the surgical procedure.
Manufacturer or healthcare provider contact
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES ยท Raw API Response
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