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.
Reported: August 9, 2023 Initiated: June 22, 2023 #Z-2253-2023
Product Description
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.
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).
Details
- Recalling Firm
- Wilson-Cook Medical Inc.
- Units Affected
- 402 units
- Distribution
- Worldwide distribution.
- Location
- Winston Salem, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Wilson-Cook Medical Inc.. Units affected: 402 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2253-2023.
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