FDA-Device2023-08-09Class II
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Wilson-Cook Medical Inc.
Hazard
Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).
Sold states
Worldwide distribution.
Affected count
393 units
Manufactured in
4900 Bethania Station Rd, N/A, Winston Salem, NC, United States
Products
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief