Reported Jul 10, 2024 · Ongoing
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual…
Megadyne Medical Products, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Megadyne Medical Products, Inc. · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
- Brand NameMEGADYNE" MEGA SOFT" Dual Reusable
- Patient Return Electrode Product NameMEGADYNE" MEGA SOFT" Dual Reusable Patient
- Return Electrode Model/Catalog Number0835
- Software VersionN/A
- Product DescriptionReusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm
- Thick ComponentNo
- Lot codes and dates
- Product Code0835
- UDI-DI10614559101872
- Lot NumberAll distributed lot numbers. Product code has been discontinued from future production
- Amount recalled
- 1463 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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