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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Denali IVC Filter

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 Class 2 Device Recall Bard Denali IVC Filtersee related information
Date Initiated by FirmMarch 13, 2015
Date PostedFebruary 01, 2016
Recall Status1 Terminated 3 on February 01, 2016
Recall NumberZ-0737-2016
Recall Event ID 72945
510(K)NumberK130366 
Product Classification Filter, intravascular, cardiovascular - Product Code DTK
ProductDenali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Code Information Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699  Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information ContactAlan Rodrigues
800-321-4254
Manufacturer Reason
for Recall		IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
FDA Determined
Cause 2		Labeling Change Control
ActionThe firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada
Quantity in Commerce1,183 units
DistributionDistributed to CA only.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTK
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