FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0817-04
- Recalling firm
- Bacchus Vascular Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2003-11-24
- Posted
- 2004-07-20
- Terminated
- 2004-05-06
- 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: 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.
- Lot, serial or model codes
- Lot Numbers: M02-50380, M02-50381, M02-50382, P03-30000, P03-30006, P03-30007, P03-30010, P03-30011, P03-30012, P03-30014, P03-30019, P03-30030, P03-30031, P03-30032, P03-30035, P03-30036, P03-30037, P03-30041, P03-30043, P03-30045, P03-30051, P03-30052, P03-30053, P03-30055, P03-30056, P03-30059, P03-30061, P03-30062, P03-30063, P03-30067, P03-30069, P03-30071, P03-30072, P03-30073, P03-30076, P03-30077, P03-30078, P03-30079, P03-30080, P03-30081, P03-30085, P03-30086, P03-30087, P03-30088, P03-30091, P03-30093, P03-30095, P03-30096, P03-30100, P03-30101, M03-50338, M03-50339, P03-30107, P03-30108, P03-30113, P03-30114
- 510(k) numbers
- ["K023514"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3003243511
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28