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.
Product labeling; units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
조치
Consignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the product. A local sales representative or customer service should be contacted with questions at 1-866-246-6990.
Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
제품 설명
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. || Designed for oral and nasal intubation and are indicated for airway management.