Vado Bi-Directional Steerable Sheath 8.8F recall
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.
Why was Vado Bi-Directional Steerable Sheath 8.8F 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.
- 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.
- Recalling firm
- Kalila Medical
- Quantity
- 261 sheaths
- Distribution
- 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.
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)