Class 2 Device Recall Fusion Lithotripsy Extraction Baskets

• Date Initiated by Firm: June 22, 2023
• Date Posted: July 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2252-2023
• Recall Event ID: 92648
• Product Classification: Dislodger, stone, basket, ureteral, metal - Product Code FFL
• 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.
• Code Information: UDI/DI 00827002482777, 10827002482774, Lot Numbers: W4589620, W4589141, W4596704, W4596704, W4589141, W4715238, W4596704, W4715238, W4715238, W4646708, W4644270, W4596704, W4589141, W4589141, W4715238, W4646708, W4715238, W4660182, W4596704, W4660182, W4660182, W4589141, W4596704, W4660182, W4715242, W4644270, W4589620, W4664573, W4646708, W4660182, W4589141, W4589620, W4644270, W4660182, W4660182, W4589620, W4644270, W4596704, W4644270, W4664573, W4644270, W4644270, W4646708, W4715238, W4664573, W4608745, W4670102, W4697072, W4697068, W4697072, W4696416, W4660182, W4620539, W4620539, W4620539, W4651764, W4651764, W4670097, W4664041, W4661895, W4647284, W4589621, W4693149, W4645756, W4594582, W4596701, W4612933, W4647284, W4664041, W4612933, W4643861, W4645763, W4594582, W4589621, W4635967, W4631138, W4644271, W4645308, W4645755, W4645756, W4647284, W4631138, W4596701, W4597312, W4612932, W4664041, W4594582, W4594582, W4597312, W4645755, W4661895, W4645763, W4571161, W4608304, W4610258, W4612932, W4612933, W4635967, W4645755, W4645755, W4693149, W4610258, W4596701, W4597312, W4645308, W4647284, W4635967, W4645308, W4693149, W4645763, W4571161, W4597312, W4612933, W4631138, W4631932, W4631932, W4571161, W4662353, W4635967, W4608304, W4612932, W4661895, W4645756, W4635967, W4635967, W4631932, W4635967, W4612933, W4631138, W4645308, W4596701, W4608304, W4662353, W4693149, W4589621, W4612933, W4645755, W4647284, W4662353, W4610258, W4643861, W4644271, W4644271, W4645308, W4645763, W4596701, W4608304, W4608304, W4612932, W4619650, W4622436, W4631932, W4635967, W4631138, W4594582, W4643861, W4631932, W4645756, W4662353, W4664041, W4594582, W4589621, W4664041, W4662353, W4612933, W4612933, W4631138, W4612933, W4631138, W4596704, W4589141
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• For Additional Information Contact: Cook Medical Customer Relations; 800-457-4500
• Manufacturer 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).
• FDA Determined Cause: Process control
• Action: Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice to their consignees on 07/14/2023 by email or priority mail. The notice explained the issue, the risk, and requested the consignee cease use and return the affected product.
• Quantity in Commerce: 393 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.