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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Kalila Medical
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
Distribution:
Distributed in: DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0563-2018
Related Recalls
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.