Class 1 Device Recall MEGADYNE MEGA SOFT Pediatric Patient Return Electrode

• Date Initiated by Firm: May 08, 2024
• Date Posted: June 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1920-2024
• Recall Event ID: 94544
• 510(K)Number: K080741
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: 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: Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
• Recalling Firm/ Manufacturer: Megadyne Medical Products, Inc.; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: N/A; 513-337-7300
• Manufacturer Reason for Recall: Reports of patient burns.
• FDA Determined Cause: Device Design
• Action: 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 ethicon4284@sedgwick.com 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.
• Quantity in Commerce: 1270
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI