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
Cannula, sinus - Product Code KAM
원인
Acclarent determined that one single relieva flex sinus guide catheter was distributed past it's expiry date.
조치
Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions.
Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.
RELIEVA FLEX Sinus Guide Catheter F-70. || Catalog number GC070RF. || Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. || .