Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
FDA Recall Z-2253-2023 · Posted 2023-07-28
Recalling FirmWilson-Cook Medical Inc.
Recall StatusOpen, Classified
Product CodeFFL
Date Initiated2023-06-22
Product Quantity402 units
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).
Firm Action
Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice to their consignees on 07/14/2023 by email or priority mail. The notice explained the issue, the risk, and requested the consignee cease use and return the affected product.
Root Cause
Process control
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.