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
Lancing Device - Product Code FMK
원인
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
조치
The firm has conducted a health hazard evaluation, and has initiated a corrective action plan. The firm initated recall on March 30, 2007, and notifications were sent to hospital end users known to Lifescan and its direct accounts. In addition, a customer service script has been developed to address any questions from incoming users.
The firm has requested direct accounts to perform subrecalls on Lifescan's behalf to notify customers of the recall as needed.