Reported Dec 13, 2023 · Ongoing
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wilson-Cook Medical Inc. · 4900 Bethania Station Rd · Winston Salem, NC · 27105-1203
Is this the product you have?
- QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
- Lot codes and dates
UDI/DI 00827002226555 (each)10827002226552 (case)
- Lot Numbers
W4721265W4737428W4740108W4741851W4742110W4742520W4742521W4743198W4744020W4744440W4744875W4749508W4752283W4756468W4720846W4721267W4721796W4722643W4722984W4723305W4723845W4737430W4737767W4738715W4739351W4742522W4742526W4743195W4743196W4744021W4744023W4744443W4744874W4744876W4748041W4748965W4749745W4750014W4750263W4751108W4751109W4751510W4751905W4751907W4753815W4753817W4754120W4754121W4754253W4756473W4758166W4758167W4758929W4758930W4760296W4760714W4761223W4762154
- Amount recalled
- 941 devices
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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