Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B; One Shot Introducer System, non-sterile, export only for further processing; ZRB-26-WCE. 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 rupture main body graft, preloaded graft measuring 26 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B; One Shot Introducer System, non-sterile, export only for further processing; ZRB-26-WCE.