Denali Filter-Jugular/Subclavian DL950J Denali recall
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Why was Denali Filter-Jugular/Subclavian DL950J Denali recalled?
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1,183 units
- Distribution
- Distributed to CA only.
- Recall date
- February 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)