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MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for pati...

FDA Recall #Z-1920-2024 — Class I — May 8, 2024

Recall #Z-1920-2024 Date: May 8, 2024 Classification: Class I Status: Ongoing

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.

Reason for Recall

Reports of patient burns.

Recalling Firm

Megadyne Medical Products, Inc. — Blue Ash, OH

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product 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.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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