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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-2831-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB,
P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syn...
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2
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08/21/2020
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Datascope Corporation
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Z-2847-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surg...
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2
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08/21/2020
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Datascope Corporation
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Z-2833-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-0...
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2
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08/21/2020
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Datascope Corporation
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Z-2834-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09.
Product Usage: Indications For...
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2
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08/21/2020
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Datascope Corporation
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Z-2835-2020 - 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...
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2
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08/21/2020
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Datascope Corporation
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Z-2836-2020 - 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: Acut...
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2
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08/21/2020
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Datascope Corporation
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Z-2837-2020 - 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 Cor...
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2
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08/21/2020
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Datascope Corporation
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Z-2838-2020 - 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...
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2
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08/21/2020
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Datascope Corporation
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Z-2839-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, ...
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2
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08/21/2020
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Datascope Corporation
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Z-2840-2020 - Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB
Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07...
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2
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08/21/2020
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Datascope Corporation
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