Z-0816-04

Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR...

Name: Z-0816-04 Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR...
Creator: Bacchus Vascular Inc
Published: 2003-11-24
License: https://open.fda.gov/license/

Bacchus Vascular, Inc. / initiated 2003-11-24 / Terminated

FDA source

Bacchus Vascular Inc began a recall of Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20 on 2003-11-24. The reason FDA records is "The device has the potential for fractures at the distal end during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-04
Status: Terminated
Initiated: 2003-11-24
Posted: 2004-07-20
Terminated: 2004-05-06
Recalling firm: Bacchus Vascular, Inc.
Product: Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20
Product code: KRA Catheter, Continuous Flush
Reason for recall: The device has the potential for fractures at the distal end during use.
FDA 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 in commerce: 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: NETHERLANDS, Argentina, ISRAEL, Czech Republic, ARGENTINA, GERMANY, AUSTRIA, SWITZERLAND, IRELAND, HONG KONG, GERMANY, GREECE, Belgium, SOUTH AFRICA, UK, ITALY, UK, and NORWAY There is no known U. S. Government or Canadian distribution.
Product codes and lots: Lot Numbers: M02-50216, M02-50217, M02-50219, M02-50220, M02-50227, M02-50228, P02-30014, P02-30013

Product code KRA

K021958Class IITrellis Plus Infusion System (140Cm Catheter Length 10Cm Infusion Length 20Cm (100Cm Catheter Length 10Cm Infusion HBacchus Vascular, Inc. / cleared 2002-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)