MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Summary
The FDA issued a Class I for MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during el by Megadyne Medical Products, Inc.. Reason: Firm has received reports of patient burns in surgical procedures where device was used..
Details
Source
Device Recall
External ID
Z-2000-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Lot/Code Info: Model No. 0848; UDI-DI: 10614559104859; All Units.
Quantity Affected: 21,100 units
Reason for Recall
Firm has received reports of patient burns in surgical procedures where device was used.
Distribution
Distributed US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-01
Company
Blue Ash, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Megadyne Medical Products, Inc. has 19 FDA actions in our database, including 17 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Megadyne Medical Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Megadyne Medical Products, Inc. have FDA actions?
Megadyne Medical Products, Inc. has 19 FDA actions in our database, including 17 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2000-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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