Recall Z-0457-2024— Wilson-Cook Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2023-11-03. It names one FDA 510(k) clearance: K171223. Product: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree. Reason: 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..
- Recalling firm
- Wilson-Cook Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-03
- Firm location
- Winston Salem, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.