MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. recall
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long…
Why was MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. recalled?
Reports of patient burns.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.
- Product
- MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long…
- Recalling firm
- Megadyne Medical Products, Inc.
- Quantity
- 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.
- Recall date
- June 12, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)