medical Class II Updated 2020-09-02

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plu

Recalled Product

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Hazard / Issue

Potential Endotoxin Contamination

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Kit Lot Number: 3000102215 3000102248 3000102249 3000103405 3000103406 3000105261 3000105262 3000106963 3000107331 3000107332 3000108589 3000108881 3000110520 3000111682 3000113810 3000046748 3000102329 3000103404
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