MEGADYNE MEGA SOFT Return Electrode Recalled for Burns During Surgical Procedures
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical procedures.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall with documented patient injury reports (burns) occurring during use. FDA Class I classification indicates a reasonable probability of serious adverse health consequences, and the reported patient burns confirm actual harm has occurred.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (Model No. 0848). The device is used as a return electrode during electrosurgical procedures to complete the electrical circuit during surgery.
The company has received reports of patient burns occurring during surgical procedures where the device was used. This Class I recall indicates a reasonable probability that the device use could cause serious adverse health consequences.
The recalled devices were distributed nationwide across the United States. Affected units have UDI-DI 10614559104859. Approximately 21,100 units are subject to this recall.
Healthcare facilities and surgical centers currently using this device should immediately cease use and contact Megadyne Medical Products for replacement units or further guidance. Patients who have undergone surgical procedures with this device and experienced burns or other adverse effects should contact their healthcare provider.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 0848
- UDI-DI: 10614559104859
- All Units.
Distribution
Distributed nationwide across the United States.
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