medical Class II Updated 2023-12-13

Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Num

Recalled Product

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

Hazard / Issue

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.

Issued by

FDA

Distribution: US

Lot/Code Info: UDI/DI 00827002226562 (each), 10827002226569 (case), Lot Numbers: W4737768, W4746516, W4746916, W4747433, W4747834, W4748247, W4748468, W4748476, W4748944, W4749747, W4750013, W4751335, W4754263, W4756372, W4757274, W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4738716, W4740112, W4746518, W4746918, W4747435, W4747436, W4748248, W4748467, W4748963, W4749746, W4750869, W4751107, W4751110, W4751516, W4752277, W4752278, W4752280, W4752905, W4754118, W4754254, W4754257, W4756474, W4757277, W4758165, W4760467, W4760864, W4761747, W4762155

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