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Megadyne Medical Products, Inc. Recall 92409

Description: MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc. Recall 92409 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2001-2023
Event ID92409
Event DescriptionMEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Product TypeDevices
DistributionDistributed US Nationwide.
Quantity21,100 units
Recall ReasonFirm has received reports of patient burns in surgical procedures where device was used.
Device Classification20230705
Device Code InfoModel No. 0846; UDI-DI: 10614559104248; All Units.
Center Classification Date20230629
Recall Initiation Date20230601
Recalling FirmMegadyne Medical Products, Inc.
Initial Notification Letter
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