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
Tape and bandage, adhesive - Product Code KGX
원인
The manufacturers seal may not be present on the nylon pouch resulting in lack of assurance for sterility.
조치
Zipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.
Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
제품 설명
Zip 8M Wound Closure Device; || for wounds up to 8 cm in length; || Product number PS9080; || Rx only, Sterile || Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.