Reusable Patient Return Electrode Recalled Due to Burn Risk
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with identified burn injury risk. The agency's Class I classification establishes a minimum severity score of 4 per the rubric, and the documented risk of patient burns justifies this rating.
Plain-English summary
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes (Model 0835) manufactured by Megadyne Medical Products, Inc. have been recalled by the FDA. Approximately 1,463 units have been distributed nationwide and internationally.
The recall is due to an identified risk of patient burns associated with use of the product. The FDA has classified this as a Class I recall. To mitigate this risk, use of these electrodes should be limited to patients aged 12 or older.
Healthcare facilities and medical providers currently using these electrodes should take immediate action to restrict their use to patients aged 12 and older. Users are advised to review manufacturer guidance and the FDA recall notice for additional information.
The recalled product
- Product
- Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adu
- 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 (2)
- Product Code: 0835
- UDI-DI: 10614559101872
Distribution
Distributed nationwide across the United States.
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