Recall Z-0737-2016
Bard Peripheral Vascular Inc · initiated March 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Codes / lots: 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
Reason for recall
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
FDA-determined cause: Labeling Change Control
Action taken
The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada
Details
- Recall number
- Z-0737-2016
- Initiated
- March 13, 2015
- Posted by FDA
- February 1, 2016
- Terminated
- February 1, 2016
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Quantity
- 1,183 units
- Distribution
- Distributed to CA only.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ