Recall Z-2252-2023 ยท FFL Dislodger, Stone, Basket, Ureteral, Metal
Wilson-Cook Medical Inc.
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.
| Date | Jul 28, 2023 (initiated Jun 22, 2023) |
| Status | Open, Classified |
| 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). |
| Root cause | Process control |
| 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. |
| Quantity | 393 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.