Z-0311-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- September 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Product Description
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Reason for Recall
There is discrepant labeling on the inner and outer packaging of the device.
Distribution Pattern
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Code Information
UDI-DI: 10607567107974; Lot Number: 3000344298