FDAFDA · Food and drugs·Recall number Z-1920-2024
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.
Published June 12, 2024 · Recall initiated: May 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of patient burns.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Megadyne Medical Products, Inc.
- Distributor
- 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.
- Lot
- Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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