QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; 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-0463-2024
- Quantity
- 157 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 00827002227668 (each), 10827002227665 (case), Lot Numbers: W4756462, W4756900, W4720847, W4722980, W4723309, W4723843, W4724323, W4739834, W4739836, W4740110, W4746517, W4748042, W4749743, W4750261, W4750868, W4751105, W4751508, W4751913, W4752281, W4752574, W4753814, W4754251, W4754849, W4756902, W4757276, W4757730, W4757733, W4758164, W4758169, W4758646, W4759510, W4759975, W4761222, W4761227, W4762146, W4762152, W4762386, W4762626
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.