Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
FDA device recall Z-0737-2016 · posted 2016-02-01 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
- 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
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DTK
- Quantity affected
- 1,183 units
- Distribution
- Distributed to CA only.
- Date initiated
- 2015-03-13
- Date posted
- 2016-02-01
- Date terminated
- 2016-02-01
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT (K130366) | C.R. Bard, Inc. | 2013-05-15 |