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Quantum TTC recallZ-0458-2024 · Wilson-Cook Medical Inc. · initiated Nov 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Wilson-Cook Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0458-2024
Status
Open, Classified
Initiated by the company
Nov 3, 2023
Posted by the FDA
Dec 1, 2023
Recalling firm
Wilson-Cook Medical Inc.
Quantity
111 devices
Product code
FGE
FDA submissions
K171223
Distribution
US

Product description

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93326).

Sources and updates

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