Fusion Lithotripsy Extraction Basket
Brand(s)
Last updated
Summary
Product
Fusion Lithotripsy Extraction Basket
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Fusion Lithotripsy Extraction Basket | Not applicable. | FS-LXB-3X6 FS-LXB-2X4 |
Issue
An investigation that confirmed nonconforming baskets were manufactured/distributed. This can appear in field as inability to advance or retract basket or drive wire breaking or separating from handle (with or without mechanical lithotripsy). Investigation found that bit on electric torque wrench was stripped preventing wrench from applying sufficient torque to cannula to secure drive wire. Faulty torque wrench was removed from production line and operators were retrained on torquing process.
Recall start date: July 10, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Wilson-Cook Medical, Inc. |
| 4900 Bethania Station Rd., Winston Salem, North Carolina, United States, 27105 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73964
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