Z-1920-2024 Class I Ongoing
FDA device recall Z-1920-2024 was initiated by Megadyne Medical Products, Inc. on May 8, 2024 and is designated Class I. Reason for recall: Reports of patient burns. The recall status is ongoing. Affected quantity: 1270.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- May 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1270
Product 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 for Recall
Reports of patient burns.
Distribution Pattern
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.
Code Information
Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.