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Wilson-Cook Medical Inc. recalls QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Recalled December 13, 2023 · FDA recall Z-0457-2024 · Wilson-Cook Medical
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. · FDA Class II
Units
731 devices
Sold at
US
Description
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.
Product
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Manufacturer(s)
Wilson-Cook Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →