Z-1999-2023 Class I Ongoing
FDA device recall Z-1999-2023 was initiated by Megadyne Medical Products, Inc. on June 1, 2023 and is designated Class I. Reason for recall: Firm has received reports of patient burns in surgical procedures where device was used. The recall status is ongoing. Affected quantity: 21,100 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- June 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,100 units
Product Description
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Reason for Recall
Firm has received reports of patient burns in surgical procedures where device was used.
Distribution Pattern
Distributed US Nationwide.
Code Information
Model No. 0847; UDI-DI: 10614559104842; All Units.