The Recall Desk

FDA (Devices) recall action 78824

Kalila Medical recalled 2 products on 2018-02-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-02-21
Critical
0
Units
360

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-02-21

    Kalila Medical Recalls Vado Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 99 Vado Steerable Sheaths because internal testing detected torn liner material at the proximal end, potentially caused by manufacturing damage.

    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.
    Category
    Distribution
    11 states
  • HighFDA (Devices)··2018-02-21

    Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner

    Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.

    Product
    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.
    Category
    Distribution
    11 states