Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20
FDA device recall Z-0816-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Bacchus Vascular Inc
- Reason for recall
- The device has the potential for fractures at the distal end during use.
- Action taken
- On 11/24/03, all consignees were notified via phone calls and/or on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 1260 units
- Distribution
- Product was released for distribution to 131 consignees in US. The firm identified 18 foreign distributors that received recall products. The product received nationwide distribution. The firm has als
- Date initiated
- 2003-11-24
- Date posted
- 2004-07-20
- Date terminated
- 2004-05-06
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H (K021958) | Bacchus Vascular, Inc. | 2002-07-03 |