FDA-Device2023-12-13Class II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
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.
Sold states
US
Affected count
111 devices
Manufactured in
4900 Bethania Station Rd, Winston Salem, NC, United States
Products
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2024Don't want to check this manually?
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