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.
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
조치
On October 19, 2017 an URGENT MEDICAL DEVICE RECALL letter was mailed to customers requesting that they examine inventory for affected product, immediately quarantine and return product to recalling firm for credit. Questions or concerns can be directed to 1-800-457-4500 or 812-330-2235.
Mallinckrodt Institute Percutaneous Gastrostomy Set || Product Usage: || Intended for the percutaneous placement of a catheter for gastroenteric feeding