Fusion Lithotripsy Extraction Baskets recalled for mechanical defects
Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves mechanical defects that could impair proper function during a medical procedure. No injuries or illnesses are reported in the source text. The score reflects the risk-of-harm nature of the defect in the absence of reported patient harm.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 393 units of the Fusion Lithotripsy Extraction Basket, Model FS-LXB-2X4, worldwide. These devices are intended for endoscopic removal of biliary stones and foreign bodies.
The recalled baskets may fail to advance or retract properly, or the drive wire may break or separate from the handle during use, with or without mechanical lithotripsy. These mechanical defects could prevent successful completion of the intended procedure.
Healthcare providers and facilities that have received these devices should immediately identify affected units by lot number and discontinue use. Affected lot numbers are provided in FDA recall notice Z-2252-2023. Physicians and medical staff should contact Wilson-Cook Medical for guidance on device disposition and replacement options.
The recalled product
- Product
- 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.
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- mechanical-failure
- wire-breakage
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00827002482777
- 10827002482774
- Lot Numbers: W4589620
- W4589141
- W4596704
- W4715238
- W4646708
- W4644270
- W4660182
- W4715242
- W4589620
- W4664573
- W4608745
- W4670102
- W4697072
- W4697068
- W4696416
- W4620539
- W4651764
- W4670097
Distribution
Distribution scope not specified by the agency.
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