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
Hook, surgical, general & plastic surgery - Product Code GDG
원인
Teleflex medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. if the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.
조치
The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock.
If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Weck, DuraHook ¿ (6mm) and ¿ (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper, Rx Only, Teleflex Medical, Research Triangle Park, NC 277809. || For use as skin retraction devices during general surgery. DuraHooks are also cleared for use in procedures requiring retraction of dura mater.