Reported Mar 16, 2016 · Terminated

Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of…

Bard Peripheral Vascular Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St · Tempe, AZ · 85281-2438

Is this the product you have?

  • Denali Filter-Jugular/Subclavian
  • Delivery System Product CodeDL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava
Lot codes and dates
  • Product # Lot #

    112 of 112 codes

    • DL900J
    • GFZJ0450
    • DL900J
    • GFZJ0452
    • DL900J
    • GFZJ0455
    • DL900J
    • GFZK0303
    • DL900J
    • GFZJ0454
    • DL900J
    • GFZK0304
    • DL900J
    • GFZK0306
    • DL950J
    • GFZJ1176
    • DL950J
    • GFZJ1177
    • DL900J
    • GFZK0309
    • DL900J
    • GFZK0305
    • DL900J
    • GFZK0308
    • DL900J
    • GFZJ0456
    • DL900J
    • GFZK0307
    • DL900J
    • GFZJ0460
    • DL900J
    • GFZJ0459
    • DL900J
    • GFZK0310
    • DL900J
    • GFZK0311
    • DL900J
    • GFZK0314
    • DL900J
    • GFZK0313
    • DL900J
    • GFZK0312
    • DL900J
    • GFZK0315
    • DL900J
    • GFZK0316
    • DL900J
    • GFZK0317
    • DL900J
    • GFZK0358
    • DL900J
    • GFZK0318
    • DL900J
    • GFZK0319
    • DL900J
    • GFZK0360
    • DL900J
    • GFZK0361
    • DL950J
    • GFZK0350
Amount recalled
2904

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 13, 2016 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.