Recall Z-2842-2020— Datascope Corporation
Class II · Ongoing
Class II FDA medical device recall by Datascope Corporation, initiated 2020-07-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01. Reason: Potential Endotoxin Contamination.
- Recalling firm
- Datascope Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-27
- Firm location
- Fairfield, NJ, United States
Product description
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
Reason for recall
Potential Endotoxin Contamination
Data sourced from openFDA. This site is unofficial and independent of the FDA.