Home / Recalls / Datascope Corporation / Z-0932-2020

Z-0932-2020 Class II Terminated

Recalled by Datascope Corporation — Fairfield, NJ

Recall Details

Product Type
Devices
Report Date
February 12, 2020
Initiation Date
November 20, 2019
Termination Date
June 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102

Product Description

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.

Reason for Recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Distribution Pattern

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

Code Information

Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT

Other recalls by Datascope Corporation

  • Z-1687-2022 Class II — Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter (August 5, 2022)
  • Z-1685-2022 Class II — MEGA 8Fr 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-0131-2023 Class II — LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra (August 5, 2022)
  • Z-2836-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Ki (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-2845-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Jap (July 27, 2020)
  • Z-2844-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Ja (July 27, 2020)
  • Z-2843-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Ja (July 27, 2020)
  • Z-2839-2020 Class II — Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 06 (July 27, 2020)