FDA-Device2023-07-05Class I

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

Megadyne Medical Products, Inc.
Hazard

Firm has received reports of patient burns in surgical procedures where device was used.

Sold states
Distributed US Nationwide.
Affected count
21,100 units
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2001-2023

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