Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended
FDA device recall Z-2252-2023 · posted 2023-07-28 · Open, Classified
Recall details
- Recalling firm
- Wilson-Cook Medical Inc.
- 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).
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FFL
- Quantity affected
- 393 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-06-22
- Date posted
- 2023-07-28
- Location
- Winston Salem, NC
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