QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures...
FDA Recall #Z-0459-2024 — Class II — November 3, 2023
Product Description
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
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.
Recalling Firm
Wilson-Cook Medical Inc. — Winston Salem, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
553 devices
Distribution
US
Code Information
UDI/DI 00827002226548 (each), 10827002226545 (case), Lot Numbers: W4720848, W4721792, W4721795, W4722159, W4722981, W4723304, W4723846, W4724692, W4737576, W4738717, W4742525, W4743193, W4743605, W4743606, W4743607, W4743608, W4744022, W4744441, W4748043, W4748946, W4749748, W4750264, W4750265, W4750910, W4751772, W4751906, W4751914, W4753360, W4753361, W4753362, W4753365, W4753816, W4755138, W4756901, W4756903, W4756905, W4757732, W4758647, W4759511, W4759976, W4760715, W4761738, W4761740, W4761935, W4762150
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated