Class 2 Device Recall Vado 8.8F Steerable Sheath

• Date Initiated by Firm: December 14, 2017
• Create Date: February 09, 2018
• Recall Status: Terminated on December 14, 2018
• Recall Number: Z-0563-2018
• Recall Event ID: 78824
• 510(K)Number: K160721
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Vado Steerable Sheath 8.8F, REF SS8FMU67, 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.
• Code Information: Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
• Recalling Firm/ Manufacturer: Kalila Medical; 745 Camden Ave Ste A; Campbell CA 95008-4146
• For Additional Information Contact: John D. Boselli; 410-392-7289
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
• Quantity in Commerce: 99 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB