FDAFDA · Food and drugs·Recall number Z-0563-2018
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.
Published February 21, 2018 · Recall initiated: December 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kalila Medical
- Distributor
- 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.
- Lot
- Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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