🔍 RecallPedia

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?

  1. 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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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

Related Recalls

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Wilson-Cook Medical

Class I - Dangerous

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

Nov 3, 2023 Other Medical Devices View Details →