Wilson-Cook Medical Inc. Recall 93326
Description: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc. Recall 93326 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0459-2024 |
Event ID | 93326 |
Event Description | QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree |
Product Type | Devices |
Distribution | US |
Quantity | 553 devices |
Recall Reason | 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. |
Device Classification | 20231213 |
Device 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 |
Center Classification Date | 20231201 |
Recall Initiation Date | 20231103 |
Recalling Firm | Wilson-Cook Medical Inc. |
Initial Notification | Letter |
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