Wilson-Cook recalls Fusion Lithotripsy Extraction Baskets (Model FS-LXB-2X4 G48277) due to potential inability to advance/retract or drive wire breaking. Affected units have specific lot numbers and UDI/DI codes.
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).
Wilson-Cook is recalling certain Fusion Lithotripsy Extraction Baskets that may not function properly or cause the drive wire to break during use. This could lead to complications in removing biliary stones or foreign bodies.
The baskets may fail to advance or retract properly, or the drive wire could break and separate from the handle. This could cause the basket to become stuck or malfunction during procedures to remove biliary stones or foreign bodies.
Medical professionals using these baskets for endoscopic procedures are most at risk. Patients undergoing biliary stone removal with these specific models may be affected.
Check for the model number FS-LXB-2X4 G48277 and lot numbers listed in the UDI/DI codes (00827002482777, 10827002482774) or the specific batch numbers provided in the recall list.
Identify the model number and lot numbers from the product's UDI/DI codes or batch numbers listed in the recall notice.
The baskets may not function properly or cause the drive wire to break during use, which could lead to complications in removing biliary stones or foreign bodies.
The recall does not specify a remedy, so contact Wilson-Cook Medical Inc. for further instructions.
Yes, affected units have specific lot numbers listed in the UDI/DI codes (00827002482777, 10827002482774) or the batch numbers provided in the recall list.
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-2252-2023 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-2252-2023 from Wilson-Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
