QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
This recall is currently active, issued December 1, 2023. It was issued by Wilson-Cook Medical Inc.
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- November 3, 2023
- Posted
- December 1, 2023
- Recall Number
- Z-0458-2024
- Quantity
- 111 devices
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
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.
Distribution
US
Lot / Code Info
UDI/DI 00827002227675 (each), 10827002227672 (case), Lot Numbers: W4739833, W4749234, W4750262, W4756463, W4756465, W4720843, W4722160, W4722641, W4723307, W4724321, W4739835, W4740109, W4740421, W4746519, W4747434, W4748249, W4749510, W4749744, W4750867, W4751104, W4751904, W4752276, W4752565, W4752902, W4752908, W4755364, W4756899, W4757275, W4758645, W4759509, W4760713, W4761742, W4761743
Root Cause
Under Investigation by firm
Action Taken
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.