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.
Hazard
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.
What You Should Do
Remedy
The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.
Affected by this recall?
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Products
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,
- Brand
- Kalila Medical
- UPC
- Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
Units Affected
99 sheaths