Events

Recall of Device Recall Trellis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bacchus Vascular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27855
  • Event Risk Class
    Class 2
  • Event Number
    Z-0817-04
  • Event Initiated Date
    2003-11-24
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30640
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, Continuous Flush - Product Code KRA
  • Reason
    The device has the potential for fractures at the distal end during use.
  • 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.

Device

Device Recall Trellis
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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
  • Manufacturer
    Bacchus Vascular Inc

Manufacturer

Bacchus Vascular Inc
  • Manufacturer Address
    Bacchus Vascular Inc, 3110 Coronado Dr, Santa Clara CA 95054-3205
  • Source
    USFDA