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.
FDA Recall Z-0564-2018 · Posted None
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Recalling FirmKalila Medical
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-12-14
Date Terminated2018-12-14
Product Quantity261 sheaths
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.
Firm Action
The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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