MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories recall: Labeling Error
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Why was MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories recalled?
There is discrepant labeling on the inner and outer packaging of the device.
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?
UDI-DI: 10607567107974; Lot Number: 3000344298
- Product
- MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
- Recalling firm
- Datascope Corp.
- Quantity
- 160 units
- Distribution
- International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)