QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; 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-0462-2024
- Quantity
- 888 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 00827002226562 (each), 10827002226569 (case), Lot Numbers: W4737768, W4746516, W4746916, W4747433, W4747834, W4748247, W4748468, W4748476, W4748944, W4749747, W4750013, W4751335, W4754263, W4756372, W4757274, W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4738716, W4740112, W4746518, W4746918, W4747435, W4747436, W4748248, W4748467, W4748963, W4749746, W4750869, W4751107, W4751110, W4751516, W4752277, W4752278, W4752280, W4752905, W4754118, W4754254, W4754257, W4756474, W4757277, W4758165, W4760467, W4760864, W4761747, W4762155
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.