Recall Z-0564-2018 ยท DYB Introducer, Catheter
Kalila Medical
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
| Date | Dec 14, 2017 |
| Status | Terminated |
| Reason | Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017. |
| Quantity | 261 sheaths |
| Distribution | Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162427 | Vado Bi-Directional Steerable Sheath Kalila Medical, Inc., Jan 27, 2017 |