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 - Product Code KOD
원인
Labeling inconsistency: the products have been
labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
조치
Teleflex sent an Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers with affected stock, immediately discontinue use and quarantine any affected products. To return product, customers were advised to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recall@teleflex.com. Customers with no affected stock should also complete the enclosed Recall Acknowledgment Form to confirm receipt of the letter. Customers with questions should contact Customer Service at 1-866-246-6990.