Home / Recalls / Cardiac Assist, Inc / Z-1106-2020

Z-1106-2020 Class II Terminated

Recalled by Cardiac Assist, Inc — Pittsburgh, PA

FDA device recall Z-1106-2020 was initiated by Cardiac Assist, Inc on November 19, 2019 and is designated Class II. Reason for recall: The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula. The recall status is terminated (terminated October 7, 2020). Affected quantity: 11 kits.

Recall Details

Product Type
Devices
Report Date
February 19, 2020
Initiation Date
November 19, 2019
Termination Date
October 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 kits

Product Description

TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Reason for Recall

The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

Distribution Pattern

US Nationwide distribution in the states of AZ, AL, ME, LA, PA.

Code Information

Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020

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-1951-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-29 (March 6, 2020)
  • Z-1952-2020 Class II — TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-31 (March 6, 2020)
  • Z-1949-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 57 (March 6, 2020)
  • Z-1948-2020 Class II — TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary ex (March 6, 2020)
  • Z-1950-2020 Class II — TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5 (March 6, 2020)

FDA data resources