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Terminated

Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.

FDA Recall Z-0737-2016 · Posted 2016-02-01

Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeDTK
Date Initiated2015-03-13
Date Terminated2016-02-01
Product Quantity1,183 units

Reason for Recall

IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.

Firm Action

The 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

Root Cause

Labeling Change Control

Distribution Pattern

Distributed to CA only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130366BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KITC.R. Bard, Inc. · 2013-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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