Fusion Lithotripsy Extraction Basket Recalled for Mechanical Failure
Wilson-Cook Medical is recalling Fusion Lithotripsy Extraction Baskets due to mechanical failures that may prevent proper basket advancement or retraction during biliary stone removal procedures.
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 is an FDA Class II recall of a critical endoscopic device. The mechanical failures documented—inability to advance or retract the basket or drive wire breakage—could compromise the device's intended function and pose patient safety risks, although no adverse events are reported in the source.
Plain-English summary
Wilson-Cook Medical Inc. is recalling Fusion Lithotripsy Extraction Baskets, Model Number FS-LXB-3X6 G48278, intended for endoscopic removal of biliary stones and foreign bodies. This recall affects 402 units distributed worldwide.
Non-conforming units may exhibit mechanical failures: the basket may be unable to advance or retract properly, or the drive wire may break or separate from the handle. These failures may occur during use with or without mechanical lithotripsy and could prevent successful completion of the intended procedure.
Healthcare providers and patients should immediately discontinue use of affected baskets. For information on returning devices and obtaining replacements, contact Wilson-Cook Medical Inc.
The recalled product
- Product
- 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.
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 402
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 00827002482784
- 10827002482781
- Lot Numbers: W4631139
- W4702268
- W4631139
- W4693489
- W4576227
- W4702262
- W4616511
- W4612934
- W4609498
- W4631537
- W4644272
- W4697764
- W4660177
- W4616520
- W4610273
- W4635963
- W4622445
- W4662350
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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