FDA recall Z-2252-2023

Wilson-Cook Medical Inc. · Class II · device

Product

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.

Reason for recall

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).

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-06-22
Report date
2023-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Winston Salem, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2252-2023