QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 00827002227668 (each), 10827002227665 (case), Lot Numbers: W4756462, W4756900, W4720847, W4722980, W4723309, W4723843, W4724323, W4739834, W4739836, W4740110, W4746517, W4748042, W4749743, W4750261, W4750868, W4751105, W4751508, W4751913, W4752281, W4752574, W4753814, W4754251, W4754849, W4756902, W4757276, W4757730, W4757733, W4758164, W4758169, W4758646, W4759510, W4759975, W4761222, W4761227, W4762146, W4762152, W4762386, W4762626
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Product Codes/Lot Numbers:
UDI/DI 00827002227668 (each), 10827002227665 (case), Lot Numbers: W4756462, W4756900, W4720847, W4722980, W4723309, W4723843, W4724323, W4739834, W4739836, W4740110, W4746517, W4748042, W4749743, W4750261, W4750868, W4751105, W4751508, W4751913, W4752281, W4752574, W4753814, W4754251, W4754849, W4756902, W4757276, W4757730, W4757733, W4758164, W4758169, W4758646, W4759510, W4759975, W4761222, W4761227, W4762146, W4762152, W4762386, W4762626
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0463-2024
Related Recalls
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Wilson-Cook Medical
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
Specific lots of product have been manufactured with nonconforming raw materials.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical
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.