Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extracti...
FDA Recall #Z-2253-2023 — Class II — June 22, 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).
Recalling Firm
Wilson-Cook Medical Inc. — Winston Salem, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
402 units
Distribution
Worldwide distribution.
Code Information
UDI/DI 00827002482784, 10827002482781, Lot Numbers: W4631139, W4702268, W4631139, W4631139, W4693489, W4693489, W4576227, W4702262, W4693489, W4616511, W4693489, W4612934, W4609498, W4693489, W4609498, W4576227, W4631537, W4644272, W4693489, W4702262, W4576227, W4616511, W4612934, W4576227, W4631537, W4644272, W4631537, W4616511, W4702262, W4576227, W4612934, W4576227, W4612934, W4612934, W4612934, W4693489, W4631537, W4644272, W4609498, W4609498, W4702262, W4576227, W4612934, W4576227, W4631537, W4697764, W4576227, W4616511, W4631537, W4697764, W4644272, W4697764, W4702262, W4616511, W4697764, W4702262, W4660177, W4616520, W4610273, W4616520, W4616520, W4635963, W4622445, W4662350, W4645764, W4616520, W4625161, W4701899, W4622445, W4647285, W4647285, W4647285, W4635963, W4645764, W4663702, W4701899, W4645764, W4554892, W4663702, W4701899, W4702270, W4645764, W4616520, W4622445, W4645764, W4660177, W4645764, W4701897, W4702270, W4662350, W4663702, W4662350, W4610273, W4554892, W4664043, W4589622, W4590893, W4590893, W4590893, W4594583, W4594583, W4594583, W4594583, W4594583, W4619627, W4619627, W4619627, W4619651, W4625160, W4625160, W4625160, W4631933, W4647697, W4647701, W4651755, W4651755, W4651765, W4651765, W4651765, W4664574, W4664574, W4660177, W4645764, W4622445, W4610273, W4610273, W4616520, W4625161, W4701899, W4554892, W4554892, W4622445, W4664043, W4701899, W4625161, W4647285, W4554892, W4647285, W4622445, W4702270, W4554892, W4554892, W4554892, W4635963, W4701897, W4616520, W4631139, W4631139, W4631139, W4693489, W4631139, W4644272, W4697073, W4697252, W4631535, W4616511, W4621105, W4609498, W4616511, W4609498, W4554892, W4610273, W4664042, W4693489, W4625161, W4662350, W4610273, W4635963, W4635963, W4647285, W4664043, W4625161, W4660177, W4663702, W4664043, W4701897, W4701899, W4702270, W4662350, W4662350, W4663702, W4664043, W4701897, W4609498, W4664042, W4663702, W4697764, W4664042, W4645764, W4635963, W4702262
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated