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U.S. Department of Health and Human Services

Class 2 Device Recall Vado BiDirectional Steerable Sheath 8.8F

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  Class 2 Device Recall Vado BiDirectional Steerable Sheath 8.8F see related information
Date Initiated by Firm December 14, 2017
Create Date February 09, 2018
Recall Status1 Terminated 3 on December 14, 2018
Recall Number Z-0564-2018
Recall Event ID 78824
510(K)Number K162427  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
Code Information Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.
Recalling Firm/
Kalila Medical
745 Camden Ave Ste A
Campbell CA 95008-4146
For Additional Information Contact John D. Boselli
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 2
Under Investigation by firm
Action The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
Quantity in Commerce 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.
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 and Original Applicant = KALILA MEDICAL, INC.