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
Wound Drainage Device Infection Control Kits - Product Code GCY
원인
Leakage; the kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
조치
Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.