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
photopheresis kit - Product Code LNR
원인
Higher than normal blood leaks on therakos cellex procedural kits that are intended for use with the therakos cellex photopheresis system.
조치
On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter.
On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall.
Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.