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)
- Company
- Cardiac Assist, Inc
- Recall Initiated
- March 19, 2021
- Terminated
- November 22, 2021
- Recall Number
- Z-1486-2021
- Quantity
- 13 kits
- Firm Location
- Pittsburgh, PA
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
US Nationwide distribution in the states of AL, AZ, IL, TN.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
On 3/11/2021 LivaNova issued an Urgent Medical Device Correction notice via letter notifying customers the firm identified an error with the assembly of a limited number of ProtekSolo Venous Dilator Sets. The ProtekSolo Venous Dilator Set 14-22 Fr should contain 3 dilators: 14Fr, 18Fr and 22Fr. A limited number of boxes labeled as ProtekSolo Venous Dilator Set 14-22 Fr incorrectly contain 4 dilators: 14Fr, 18Fr, 22Fr and 26Fr.