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.
데이터 추가 비고
General surgery tray - Product Code LRO
원인
Some of the components contained in the presource kits are being recalled because cardinal health has determined that the component manufacturer(s) does not have all necessary fda registrations or filings needed for this product.
조치
Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 2, 2011 to all affected consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. If the consignee does not wish to accept overlabeled product or to overlabel the product in their possession, they were asked to contact Presource Sales Operations at 800-766-0706 or their Sales Representative for further instructions. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact the following: Hospitals - Presource Sales Operations at 800-766-0706, Distributors - Distributor Management Group at 800-635-6021, and Federal Government facilities - Government Service at 800-444-1186.
For questions regarding this recall call 847-887-6412.