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U.S. Department of Health and Human Services

Class 2 Device Recall COOK MEDICAL

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 Class 2 Device Recall COOK MEDICALsee related information
Date Initiated by FirmNovember 03, 2023
Date PostedDecember 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0463-2024
Recall Event ID 93326
510(K)NumberK171223 
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Code Information 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
FEI Number 1037905
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
For Additional Information ContactCook Medical Customer Relations
800-457-4500
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionCook 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.
Quantity in Commerce157 devices
DistributionUS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGE
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