Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient
Summary
The FDA issued a Class I for Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name by Megadyne Medical Products, Inc.. Reason: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft p.
Details
Source
Device Recall
External ID
Z-2249-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
Lot/Code Info: Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
Quantity Affected: 2584 units
Reason for Recall
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Distribution
Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-17
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 147 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-2249-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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