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
Airway connector (Extension) - Product Code BZA
원인
Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. each of these valves demonstrate the appropriate direction with a red arrow.
the reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665.
if the red arrows are not followed, the valve may be placed in the circuit in the wrong.
조치
Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained.
Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990