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
Catheter, urological (antimicrobial) and accessories - Product Code MJC
원인
Incorrect unit labeling. the case label and shelf box are correct, product code 63512 and catheter size 12 french. the unit label (catheter package) may state product code 63516 and catheter size 16 french.
조치
Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471.