Recall Z-1486-2021 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Cardiac Assist, Inc
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)
| Date | Mar 19, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 13 kits |
| Distribution | US Nationwide distribution in the states of AL, AZ, IL, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set Cardiacassist, Inc., Jan 6, 2017 |