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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 22, 2023 Wilson-Cook Medical Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Wilson-Cook Medical Inc.
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).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2253-2023

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