Z-2252-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- June 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 393 units
Product Description
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.
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).
Distribution Pattern
Worldwide distribution.
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