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Class 2 Device Recall Vado 8.8F Steerable Sheath |
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Date Initiated by Firm |
December 14, 2017 |
Create Date |
February 09, 2018 |
Recall Status1 |
Terminated 3 on December 14, 2018 |
Recall Number |
Z-0563-2018 |
Recall Event ID |
78824 |
510(K)Number |
K160721
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Product Classification |
Introducer, catheter - Product Code DYB
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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
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For Additional Information Contact |
John D. Boselli 410-392-7289
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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.
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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 |
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
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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.
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510(K) Database |
510(K)s with Product Code = DYB and Original Applicant = KALILA MEDICAL, INC.
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