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Mega Soft recallZ-1920-2024 · Megadyne Medical Products, Inc. · initiated May 8, 2024

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

Reports of patient burns.

FDA root cause category: Device Design

What the company is doing

Consignees were mailed an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification, dated 5/8/24. The notification instructs consignees to examine their inventory to identify affected devices, quarantine any on-hand devices subject to the recall with a copy of the recall notice, and communicate the recall notification to all those in consignee facilities that should be informed and those facilities to which product was further distributed. Consignees are asked to return a completed Business Reply Form by email to [email protected] or by fax at 800-978-9467. All devices subject to this recall are to be returned immediately; for credit reimbursement customers must return product no later than 8/31/2024. To return product, consignees are to include a photocopy of the completed Business Reply Form in the box with returned devices and affix the pre-paid authorized shipping label on product. Extra shipping labels may be obtained by calling 888-912-7090. Consignees with any questions can contact Ethicon Resource Department at 1-877-384-4266 from 8:00 AM to 5:00 PM EST from Monday through Friday.

Recall details

Recall number
Z-1920-2024
Status
Open, Classified
Initiated by the company
May 8, 2024
Posted by the FDA
Jun 6, 2024
Recalling firm
Megadyne Medical Products, Inc.
Quantity
1270
Product code
GEI
FDA submissions
K080741
Distribution
Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, and United Kingdom.

Product description

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.

Code information (models, lots, serial numbers)

Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

4 devices cleared under K080741 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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