MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Recalled for Patient Burns
Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical 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: The FDA has classified this as a Class I recall, which meets the criteria for Critical severity. This classification reflects that there is a reasonable probability the product will cause serious adverse health consequences, which is supported by reports of patient burns in surgical procedures using the device.
Plain-English summary
Megadyne Medical Products, Inc. is recalling 21,100 units of MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (Model No. 0847, UDI-DI: 10614559104842) distributed nationwide in the United States. This device is used during electrosurgical procedures.
The recall was initiated because the manufacturer has received reports of patient burns in surgical procedures where the device was used. The FDA has classified this as a Class I recall.
Healthcare facilities and surgical centers that have used or may have unused units of this device should immediately identify the affected units and cease use. Patients who may have been exposed to this device during surgery should consult with their healthcare provider if they experience any unexplained burns or injuries.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal Plus 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. 0847
- UDI-DI: 10614559104842
- All Units.
Distribution
Distributed nationwide across the United States.
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