Home / Recalls / Datascope Corporation / Z-2846-2020

Z-2846-2020 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
3542 Kits

Product Description

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - 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: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589

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-2838-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: (July 27, 2020)
  • Z-2842-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - (July 27, 2020)