🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: June 22, 2023 Wilson-Cook Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wilson-Cook Medical Inc.
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2252-2023

Related Recalls

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

Wilson-Cook Medical

Class I - Dangerous

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

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