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 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74. 의 리콜
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.
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.
조치
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.
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 22 mm - iliac leg diameters 11 mm - main body lengths cntralateral limb 74mm ipsilateral limb 133 mm - delivery system 18 FR; Catalog no. TFB-22-74.