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
Connector, catheter - Product Code GCD
원인
Labeling: the expiration date is not stated on the labeling, there is a potential for expired product to be used.
조치
Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the
Attn: Customer Service or email to recalls@teleflex.com. A Recall Acknowledgment
Form was enclosed to be completed and returned via fax even if they have no stock.