Recall Z-0817-04 ยท KRA Catheter, Continuous Flush
Bacchus Vascular Inc
Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRE 06 100 10, BAC TRE 06 100 20, BAC TRE 06 140 10, BAC TRE 06 140 20
| Date | Jul 20, 2004 (initiated Nov 24, 2003) |
| Status | Terminated |
| Reason | The device has the potential for fractures at the distal end during use. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 also distributed products into international channels through distributors. Countries include: NET |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023514 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) Bacchus Vascular, Inc., Dec 2, 2002 |