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
Retractor - Product Code GAD
원인
Changes were implemented to the unitrac instructions for use to ensure safe use and potentially extend the life of the product. this included recommending the use of sterile cover jg901 and new quick release coupling rt02or to eliminate the need to sterilize the unitrac and a functional check was added prior to use to ensure optimal functionality of the unitrac system.
조치
A letter dated July 16, 2013 was sent requesting users to review the new instructions for use in their entirety, sign the attached Hospital Acknowledgment form and return to Aesculap. An Aesculap representative would be in contact to provide an in-service regarding the process for set-up of the Sterile Cover and required Functional Check. Discontinuation of use and repair of the device was recommended if the joints did not move freely or if the set position drifts during the Functional Check.