Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intende
Summary
The FDA issued a Class II for Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Li by Wilson-Cook Medical Inc.. Reason: 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 (wi.
Details
Source
Device Recall
External ID
Z-2252-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 393 units
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
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-22
Company
Winston Salem, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wilson-Cook Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wilson-Cook Medical Inc. have FDA actions?
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2252-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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