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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 8.8Fsee related information
Date Initiated by FirmDecember 14, 2017
Create DateFebruary 09, 2018
Recall Status1 Terminated 3 on December 14, 2018
Recall NumberZ-0564-2018
Recall Event ID 78824
510(K)NumberK162427 
Product Classification Introducer, catheter - Product Code DYB
ProductVado 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/
Manufacturer		 Kalila Medical
745 Camden Ave Ste A
Campbell CA 95008-4146
For Additional Information ContactJohn 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 2		Under Investigation by firm
ActionThe recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
Quantity in Commerce261 sheaths
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = DYB
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