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 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - 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: 3000108682 3000108683 3000109819 3000110955 3000111683 3000111684 3000112929 3000112930 3000113624 3000113625 3000117020 3000046749 3000094529 3000094530 3000103206 3000104388 3000108351 3000112932
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