FDAFDA · Food and drugs·Recall number Z-0311-2025
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Published November 13, 2024 · Recall initiated: September 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is discrepant labeling on the inner and outer packaging of the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Datascope Corp.
- Distributor
- International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
- Lot
- UDI-DI: 10607567107974; Lot Number: 3000344298
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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