QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Recall
- Recall Number
- Z-0457-2024
- Event Number
- 93326
- Firm
- Wilson-Cook Medical Inc.
- FEI Number
- 1037905
- Product Code
- FGE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 3, 2023
- Posted
- December 1, 2023
- Address
- 4900 Bethania Station Rd, Winston Salem, NC, 27105-1203
Description
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
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.
Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice on 11/03/2023 by mail. The notice explained the problem with the device, risk to health, and requested the following actions be taken: Customer: Cease use, quarantine, and return all affected devices. If devices were further distributed, those to whom the devices were sent must be notified. Distributor: Quarantine all affected devices, notify your customers to whom you distributed devices. Return all devices to Cook Medical.
US
731 devices