Home / Recalls / Datascope Corporation / Z-2838-2020

Z-2838-2020 Class II Ongoing

Recalled by Datascope Corporation — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
September 2, 2020
Initiation Date
July 27, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1746 kits WW

Product Description

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.

Reason for Recall

Potential Endotoxin Contamination

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

Code Information

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

Other recalls by Datascope Corporation

  • Z-0131-2023 Class II — LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra (August 5, 2022)
  • Z-1685-2022 Class II — MEGA 8Fr 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-1687-2022 Class II — Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-1686-2022 Class II — Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-2839-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 06 (July 27, 2020)
  • Z-2841-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Ki (July 27, 2020)
  • Z-2847-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Jap (July 27, 2020)
  • Z-2837-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P (July 27, 2020)
  • Z-2846-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Jap (July 27, 2020)
  • Z-2842-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - (July 27, 2020)