FDA Enforcement
Class II
Ongoing
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Recall: Z-0311-2025
·
Reported November 13, 2024
Enforcement
- Recall Number
- Z-0311-2025
- Event ID
- 95396
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Datascope Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2024
- Initiation Date
- September 17, 2024
- Classification Date
- November 5, 2024
- Address
- 15 Law Dr Unit 1, N/A, Fairfield, NJ, 07004-3206, United States
Description
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Reason
There is discrepant labeling on the inner and outer packaging of the device.
Code Info
UDI-DI: 10607567107974; Lot Number: 3000344298
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.
Quantity
160 units