Reported Aug 9, 2023 · Ongoing
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are…
Wilson-Cook Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wilson-Cook Medical Inc. · 4900 Bethania Station Rd · Winston Salem, NC · 27105-1203
Is this the product you have?
- 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.
- Lot codes and dates
UDI/DI 0082700248277710827002482774
- Lot Numbers
171 of 171 codes
W4589620W4589141W4596704W4596704W4589141W4715238W4596704W4715238W4715238W4646708W4644270W4596704W4589141W4589141W4715238W4646708W4715238W4660182W4596704W4660182W4660182W4589141W4596704W4660182W4715242W4644270W4589620W4664573W4646708W4660182W4589141W4589620W4644270W4660182W4660182W4589620W4644270W4596704W4644270W4664573W4644270W4644270W4646708W4715238W4664573W4608745W4670102W4697072W4697068W4697072W4696416W4660182W4620539W4620539W4620539W4651764W4651764W4670097W4664041W4661895
- Amount recalled
- 393 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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