FDA Enforcement
Class I
Ongoing
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Recall: Z-1920-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-1920-2024
- Event ID
- 94544
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Megadyne Medical Products, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2024
- Initiation Date
- May 8, 2024
- Classification Date
- June 6, 2024
- Address
- 4545 Creek Rd, N/A, Blue Ash, OH, 45242-2803, United States
Description
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Reason
Reports of patient burns.
Code Info
Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
Distribution
Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
Quantity
1270