Home / Recalls / Cardiac Assist, Inc / Z-1952-2020

Z-1952-2020 Class II Terminated

Recalled by Cardiac Assist, Inc — Pittsburgh, PA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
March 6, 2020
Termination Date
November 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46

Product Description

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Reason for Recall

Failure to prime due to an assembly error

Distribution Pattern

US Nationwide distributions.

Code Information

Serial Numbers: 00142562 00142563 00142564 00142565 00142566 00142567 00142568 00142583 00142585 00142587 00142588 00142589 00142602 00142603 00142604 00142607 00142610 00142611 00142653 00142655 00142684 00142685 00142686 00142687 00142688 00142689 00142690 00142701 00142702 00142703 00142704 00142705 00142706 00142927 00142928 00142953 00142954 00142955 00142956 00142957 00142958 00142959 00142962 00142964 00142966 00142967

Other recalls by Cardiac Assist, Inc

  • Z-2465-2023 Class II — LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Pri (June 30, 2023)
  • Z-0926-2023 Class I — SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPA (December 5, 2022)
  • Z-1763-2022 Class I — TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 59 (July 21, 2022)
  • Z-0311-2022 Class III — SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypas (October 14, 2021)
  • Z-1486-2021 Class II — Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterizatio (March 19, 2021)
  • Z-1948-2020 Class II — TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary ex (March 6, 2020)
  • Z-1954-2020 Class II — TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3 (March 6, 2020)
  • Z-1953-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720 (March 6, 2020)
  • Z-1950-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5 (March 6, 2020)
  • Z-1949-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 57 (March 6, 2020)