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Wilson-cook Medical QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree - safety alert
Official notice
13 Dec 2023
Last checked
13 Dec 2023
An official FDA notice concerns Wilson-cook Medical QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree - safety alert. An official FDA notice concerns QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2023-12-13. Lots: W4746514. Recall numbers: Z-0457-2024. Check the official notice for the complete list. Published 2023-12-13.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
731
Recall number
Z-0457-2024
Official notice
2023-12-13
The hazard
The hazard
An official FDA notice concerns QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree. The notice reports an injury risk. Stop using the product and follow the official notice. Published 2023-12-13. Lots: W4746514. Recall numbers: Z-0457-2024. Check the official notice for the complete list.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Wilson-cook Medical. Contact: Wilson-Cook Medical Inc..
Source & status
Source & status
Recall details
Recall details
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Status
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Documents, notices & source
See the official notice and source documents for full details.
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