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
Dermatome - Product Code GFD
원인
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
조치
On April 17, 2018 Exsurco Medical hand delivered notices to customers.
Customers were advised to take the following actions:
-Review, complete and return the Customer Response Card.
-Upon verifying the information, provide the information to all Burn Account Managers.
-An Exsurco Field Service Technician will perform the correction.
Starting July 1, 2018, Exsurco Medical will issue URGENT Medical Device Recall notices and response cards to Burn Account Managers via certified mail or by hand delivery. Exsurso Medical will also provide replacement hoses simultaneously.
Burn Account Managers are advised to take the following actions:
-Review, complete and return the Customer Response Card.
-Replace all impacted X101004 Pneumatic Hoses with replacement hoses.
-Discard impacted X101004 Pneumatic Hoses as outlined in the recall notification.
Should you have any questions regarding this matter please contact (440) 204-3239/ email: saigal@exsurco.com.