Megadyne Medical Products, Inc.: Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number:

Hazard

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

Details from the source

Reason for recall: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads. Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES, Quantity: 1463 units Lot/code info: Product Code: 0835; UDI-DI: 10614559101872; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.

UPC codes

10614559101872

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.