medical Class II Updated 2020-09-02

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr

Recalled Product

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - 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: 3000046316 3000047161 3000047162 3000048615 3000049262 3000049914 3000050929 3000051380 3000052645 3000054090 3000055099 3000056537 3000059946 3000061447 3000062406 3000065986 3000066489 3000066764 3000066770 3000068730 3000069160 3000069376 3000071293 3000071739 3000073191 3000073277 3000074271 3000075134 3000075676 3000076957 3000079650 3000081778 3000084071 3000084788 3000084789 3000086924 3000085291 3000087368 3000088278 3000088570 3000090526 3000090664 3000092443 3000096052 3000097302 3000098997 3000101522 3000103209 3000106823 3000110212 3000111023 3000112113 3000058895 3000064045 3000073190 3000077204 3000084689 3000086162 3000089349 3000094526 3000103212 3000110211 3000046315 3000047053 3000047709 3000048710 3000049479 3000050215 3000050930 3000051379 3000052646 3000054089 3000055098 3000056438 3000060258 3000060259 3000061292 3000063264 3000064522 3000066679 3000065125 3000065984 3000065985 3000066515 3000066680 3000067692 3000069161 3000069872 3000069873 3000071217 3000071891 3000073192 3000074272 3000075133 3000076154 3000076956 3000079648 3000079649 3000080226 3000081779 3000083059 3000084153 3000086058 3000087369 3000088277 3000089284 3000090665 3000092442 3000094528 3000094531 3000096053 3000096054 3000098998 3000098999 3000101523 3000103210 3000106825 3000107337 3000111022 3000112114 3000046411 3000069162 3000069442 3000071837 3000094141 3000111134 3000094151 3000094527 3000096001 3000099000 3000103211 3000106824 3000107336 3000111191 3000112115
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