Wilson-Cook Medical Inc. 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0459-2024
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate… Recall
Issued December 13, 2023 · Wilson-Cook Medical Inc.
In December 2023, Wilson-Cook Medical Inc. recalled the QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Wilson-Cook Medical Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Wilson-Cook Medical Inc.
- Category
- Health
- Recall date
- December 13, 2023
- Units affected
- Not reported
- Sold at
- US
- Recall number
- FDA-Z-0459-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Wilson-Cook Medical Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.