Z-0564-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- December 14, 2017
- Termination Date
- December 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 261 sheaths
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.