Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Reported: September 14, 2022 Initiated: August 5, 2022 #Z-1687-2022
Product Description
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Reason for Recall
Certain lots containing undersized dilator.
Details
- Recalling Firm
- Datascope Corporation
- Units Affected
- 10,427 units
- Distribution
- Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- Location
- Fairfield, NJ
Frequently Asked Questions
What product was recalled? ▼
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter. Recalled by Datascope Corporation. Units affected: 10,427 units.
Why was this product recalled? ▼
Certain lots containing undersized dilator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1687-2022.
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