Wilson-Cook Medical Inc. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2253-2023
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy… Recall
Issued August 9, 2023 · Wilson-Cook Medical Inc.
In August 2023, Wilson-Cook Medical Inc. recalled the Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Wilson-Cook Medical Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Wilson-Cook Medical Inc.
- Category
- Health
- Recall date
- August 9, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-2253-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Wilson-Cook Medical Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.