Reported Feb 10, 2016 · Terminated
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
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 DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
- Lot codes and dates
- Product CodeDL950J
- Lot Number
GFYA3093GFYC3745GFYD2734GFYF3878GFYF3879GFYG3877GFYG3880
- GFYI2699 Product CodeDL950F
- Lot Number
GFYA3093GFYC3745GFYD2734GFYF3878GFYF3879GFYG3877GFYG3880GFYI2699
- Amount recalled
- 1,183 units
Where it was sold
Why it was recalled
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
This product could cause temporary or reversible health problems — stop using it.
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