Wilson-Cook recalls Quantum TTC Biliary Balloon Dilator (QBD-10X3) due to potential balloon detachment during use, which could cause injury or require retrieval. Affected units have specific lot numbers and order numbers.
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.
Wilson-Cook is recalling a specific biliary balloon dilator model because it may detach during medical procedures. This could lead to complications like bleeding or the need for retrieval, though some cases might not cause injury.
The device may detach during use, potentially causing injury from retrieval attempts or leaving the object to pass naturally. This poses a risk of bleeding or complications during endoscopic procedures.
Healthcare professionals using the Quantum TTC Biliary Balloon Dilator for biliary tree procedures are most at risk. Patients receiving this device during endoscopic treatments may also be affected.
Check for the model reference QBD-10X3 with order number G22657. Affected units have specific lot numbers listed in the recall notice, including W4746514 through W4762151.
Identify the model reference QBD-10X3 and order number G22657 on the device or packaging.
Reach out to Wilson-Cook Medical Inc. for guidance on next steps if the device is affected.
The device may detach during use, which could cause injury or require retrieval. Affected units should not be used until further instructions are received.
Check the lot numbers listed in the recall notice. If affected, contact Wilson-Cook Medical Inc. for guidance.
Look for the model reference QBD-10X3 with order number G22657 and specific lot numbers from the list provided in the recall notice.
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0457-2024 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-0457-2024 from Wilson-Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
