Events

Recall of Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 103mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-24-103.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook, 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
    29300
  • Event Risk Class
    Class 2
  • Event Number
    Z-1166-04
  • Event Initiated Date
    2004-06-10
  • Event Date Posted
    2004-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33852
  • 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
    System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
  • Reason
    Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
  • Action
    The firm issued recall letters to customers on 6/10/04. The recall was extended and URGENT EXTENSION OF PRODUCT RECALL notices were sent out on June 23, 2004.

Device

Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, prel...
  • Model / Serial
    Lots 1348491, F1530610, F1535660, F1537428,  F1537429, F1537430, F1537431, F1539286, F1539287, F1539275, F1548106, F1548107, F1541878, F1541879, F1546892, F1550308, F1552063, F1550309, F1548073, F1554819, F1548074, F1552064, F1554805, F1554806, F1554807, F1550307, F1549747, F1555823, F1560055, F1559969, F1562104, F1562105, F1562106, F1562107, F1562108, F1562109, F1562085, F1562086, F1571599, F1571600, F1572864, F1572865, F1571598, F1575127 and F1575129.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Canada, Denmark and Japan.
  • Product Description
    Cook brand Zenith AAA Bifurcated main body graft with the H&L-B; One-Shot Introducer System, preloaded bifurcated main body graft - aortic graft diameter 24 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 103mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-24-103.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA