medical Class II Updated 2023-12-13

Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Num

Recalled Product

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; 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 00827002226555 (each), 10827002226552 (case), Lot Numbers: W4721265, W4737428, W4740108, W4741851, W4742110, W4742520, W4742521, W4743198, W4744020, W4744440, W4744875, W4749508, W4752283, W4756468, W4720846, W4721267, W4721796, W4722643, W4722984, W4723305, W4723845, W4737430, W4737767, W4738715, W4739351, W4742522, W4742526, W4743195, W4743196, W4744021, W4744023, W4744443, W4744874, W4744876, W4748041, W4748965, W4749745, W4750014, W4750263, W4751108, W4751109, W4751510, W4751905, W4751907, W4753815, W4753817, W4754120, W4754121, W4754253, W4756473, W4758166, W4758167, W4758929, W4758930, W4760296, W4760714, W4761223, W4762154

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