🔍 RecallPedia

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; 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 00827002226555 (each), 10827002226552 (case), Lot Numbers: W4721265, W4737428, W4740108, W4741851, W4742110, W4742520, W4742521, W4743198, W4744020, W4744440, W4744875, W4749508, W4752283, W4756468, W4720846, W4721267, W4721796, W4722643, W4722984, W4723305, W4723845, W4737430, W4737767, W4738715, W4739351, W4742522, W4742526, W4743195, W4743196, W4744021, W4744023, W4744443, W4744874, W4744876, W4748041, W4748965, W4749745, W4750014, W4750263, W4751108, W4751109, W4751510, W4751905, W4751907, W4753815, W4753817, W4754120, W4754121, W4754253, W4756473, W4758166, W4758167, W4758929, W4758930, W4760296, W4760714, W4761223, W4762154
  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-6X3, Order Number G22655; used to dilate strictures of the biliary tree

Product Codes/Lot Numbers:

UDI/DI 00827002226555 (each), 10827002226552 (case), Lot Numbers: W4721265, W4737428, W4740108, W4741851, W4742110, W4742520, W4742521, W4743198, W4744020, W4744440, W4744875, W4749508, W4752283, W4756468, W4720846, W4721267, W4721796, W4722643, W4722984, W4723305, W4723845, W4737430, W4737767, W4738715, W4739351, W4742522, W4742526, W4743195, W4743196, W4744021, W4744023, W4744443, W4744874, W4744876, W4748041, W4748965, W4749745, W4750014, W4750263, W4751108, W4751109, W4751510, W4751905, W4751907, W4753815, W4753817, W4754120, W4754121, W4754253, W4756473, W4758166, W4758167, W4758929, W4758930, W4760296, W4760714, W4761223, W4762154

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0460-2024

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