Recall Z-0563-2018— Kalila Medical
Class II · Terminated
Class II FDA medical device recall by Kalila Medical, initiated 2017-12-14, terminated 2018-12-14. It names one FDA 510(k) clearance: K160721. 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.. Reason: 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..
- Recalling firm
- Kalila Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-14
- Terminated
- 2018-12-14
- Firm location
- Campbell, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.