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FDANovember 3, 2023device

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

wilson cook medicalwilsonwilson cook

UPCs

0082700222657910827002226576

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree — Recall Details · AllClear