Home / Recalls / Cardiac Assist, Inc / Z-1486-2021

Z-1486-2021 Class II Terminated

Recalled by Cardiac Assist, Inc — Pittsburgh, PA

Recall Details

Product Type
Devices
Report Date
May 5, 2021
Initiation Date
March 19, 2021
Termination Date
November 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 kits

Product Description

Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)

Reason for Recall

On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.

Distribution Pattern

US Nationwide distribution in the states of AL, AZ, IL, TN.

Code Information

LOT/SERIAL: 285586, 00145202, 00145204, 00871587, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567, UDI: (01) 00814112020463(17)231024(11)201024(10)285586 (01)00814112020517(17)220222(11)210118(21)00145202 (01)00814112020517(17)220222(11)210118(21)00145204 (01)00814112020708(17)210203(11)220117(21)00871587 (01)00814112020092(17)210129(11)220117(21)00871549 (01)00814112020092(17)210129(11)220117(21)00871560 (01)00814112020092(17)210129(11)220117(21)00871561 (01)00814112020092(17)210129(11)220117(21)00871562 (01)00814112020092(17)210129(11)220117(21)00871563 (01)00814112020092(17)210129(11)220117(21)00871564 (01)00814112020092(17)210129(11)220117(21)00871565 (01)00814112020092(17)210129(11)220117(21)00871566 (01)00814112020092(17)210129(11)220117(21)00871567

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