Recall Z-2252-2023— Wilson-Cook Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2023-06-22. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- Wilson-Cook Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-22
- Firm location
- Winston Salem, NC, United States
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.