MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Reported: November 13, 2024 Initiated: September 17, 2024 #Z-0311-2025
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.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 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.
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01. Recalled by Datascope Corp.. Units affected: 160 units.
Why was this product recalled? ▼
There is discrepant labeling on the inner and outer packaging of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0311-2025.
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