Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S
Summary
The FDA issued a Class I for Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, R by Megadyne Medical Products, Inc.. Reason: Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and incl.
Details
Source
Device Recall
External ID
Z-0599-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Lot/Code Info: UDI-DI 10614559104842 All units in expiry
Quantity Affected: 2,312
Reason for Recall
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Distribution
Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-08
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 94 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-0599-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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