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U.S. Department of Health and Human Services

Class 1 Device Recall MEGADYNE" MEGA 2000" Patient Return Electrode

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 Class 1 Device Recall MEGADYNE" MEGA 2000" Patient Return Electrodesee related information
Date Initiated by FirmJune 17, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2248-2024
Recall Event ID 94837
510(K)NumberK080741 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductBrand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
Code Information Product Code: 0800; UDI-DI: 10614559100936; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
Recalling Firm/
Manufacturer
Megadyne Medical Products, Inc.
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactEthicon Resource Department
513-337-7300
Manufacturer 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.
FDA Determined
Cause 2
Unknown/Undetermined by firm
ActionAn URGENT MEDICAL DEVICE CORRECTION letter, dated 6/17/24, was mailed to consignees. Consignees are instructed to share the recall notification with all users of affected devices and confirm their understanding, post a copy of the communication for user awareness, and forward the recall notification to any facility to which product was shipped. The notification reads that Mega Soft and Mega 2000 devices are only to be used for patients 12 years old. The notification also reminds consignees to follow proper cleaning, placement, and setup steps. Consignees are asked to complete and return the provided Business Reply Form by fax to 844-441-2732 or by email to Ethicon8367@sedgwick.com. Customers with any questions about the communication can contact Ethicon at 1-877-384-4266 from Monday through Friday from 8:00 AM EST to 5:00 PM EST. 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).
Quantity in Commerce259 units
DistributionDomestic: 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,
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
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