Z-0737-2016 Class II Terminated
FDA device recall Z-0737-2016 was initiated by Bard Peripheral Vascular Inc on Mar 13, 2015 and is designated Class II. Reason for recall: IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. The recall status is terminated (terminated Feb 1, 2016). Affected quantity: 1,183 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 10, 2016
- Initiation Date
- Mar 13, 2015
- Termination Date
- Feb 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,183 units
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.
Distribution Pattern
Distributed to CA only.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0737-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026