Wilson-Cook Medical Inc.: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

Hazard

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.

Details from the source

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. Distribution: US Quantity: 553 devices Lot/code info: 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

UPC codes

00827002226548, 10827002226545

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.