medical Class II Updated 2020-09-02

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr

Recalled Product

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - 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: 3000049797 3000053552 3000056193 3000056201 3000057749 3000066195 3000067965 3000069878 3000071222 3000072585 3000074287 3000078937 3000079446 3000080540 3000084470 3000090372 3000092553 3000095910 3000099930 3000103632 3000112148 3000053297 3000057125 3000072586 3000049798 3000053553 3000057748 3000061193 3000066264 3000069270 3000071221 3000072584 3000074288 3000077341 3000077814 3000083060 3000084471 3000087477 3000087478 3000088619 3000090373 3000092552 3000095911 3000099932 3000103631 3000053554 3000056540 3000061194 3000068728 3000092554 3000095912 3000099933 3000102246 3000049800 3000074289 3000092555 3000099931
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