Recall Z-0737-2016— Bard Peripheral Vascular Inc

Name: FDA recall Z-0737-2016
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2015-03-13, terminated 2016-02-01. It names one FDA 510(k) clearance: K130366. Product: Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.. Reason: IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Terminated: 2016-02-01
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K130366 — BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KITC.R. Bard, Inc.·cleared 2013-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.