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Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within...

FDA Recall #Z-0564-2018 — Class II — December 14, 2017

Recall #Z-0564-2018 Date: December 14, 2017 Classification: Class II Status: Terminated

Product Description

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.

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.

Recalling Firm

Kalila Medical — Campbell, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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.

Code Information

Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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