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Mega Soft recallZ-0599-2024 · Megadyne Medical Products, Inc. · initiated Dec 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Megadyne Medical Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On December 8, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. The updated IFU will be made available electronically at www.e-ifu.com. Customers were instructed to share the notification update with all users of Mega Soft Universal and Universal Plus pads, and to take steps to ensure that all personnel using the affected product understand and are reminded that the product is not to be used on patients under 12 years old. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET. UPDATE: Starting in September 2024, the firm communicated to new and existing consignees reiterating the use of affected devices in patients aged 12 years and older. Additionally, the firm's letter informs consignees that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet). On 3/17/25, customers were customers were notified via MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrode: Voluntary Replacement Program letters. The purpose of this letter is to communicate the availability of a labeling (pad printing) update for MEGADYNE" MEGA SOFT" Universal and Universal Plus Reusable Patient Return Electrodes and availability of these pads for replacement of your current inventory. The pad printing will now show the updated indication which is for patients age 12 years and older. The previous pad printing indicates use for patients greater than 0.8 lbs (0.35 kg). Actions Required 1. Reminder users to only use Mega Soft Patient Return Electrodes on patients 12 years and older, even though these existing devices have labeling of >0.35 kg (>0.8 lb) on the pads. Do not use them on neonates, infants, and children under the age of 12 years old. 2. Compl

Recall details

Recall number
Z-0599-2024
Status
Open, Classified
Initiated by the company
Dec 8, 2023
Posted by the FDA
Dec 26, 2023
Recalling firm
Megadyne Medical Products, Inc.
Quantity
2,312
Product code
GEI
FDA submissions
K233644
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

Product description

Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus

Code information (models, lots, serial numbers)

UDI-DI 10614559104842 All units in expiry

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93597).

Sources and updates

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