🔍 RecallPedia

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2023 Wilson-Cook Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00827002227675 (each), 10827002227672 (case), Lot Numbers: W4739833, W4749234, W4750262, W4756463, W4756465, W4720843, W4722160, W4722641, W4723307, W4724321, W4739835, W4740109, W4740421, W4746519, W4747434, W4748249, W4749510, W4749744, W4750867, W4751104, W4751904, W4752276, W4752565, W4752902, W4752908, W4755364, W4756899, W4757275, W4758645, W4759509, W4760713, W4761742, W4761743
  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:
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

Product Codes/Lot Numbers:

UDI/DI 00827002227675 (each), 10827002227672 (case), Lot Numbers: W4739833, W4749234, W4750262, W4756463, W4756465, W4720843, W4722160, W4722641, W4723307, W4724321, W4739835, W4740109, W4740421, W4746519, W4747434, W4748249, W4749510, W4749744, W4750867, W4751104, W4751904, W4752276, W4752565, W4752902, W4752908, W4755364, W4756899, W4757275, W4758645, W4759509, W4760713, W4761742, W4761743

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0458-2024

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