Device Recall MultiLumen Hemodialysis Catheterization Kit 의 리콜

Recall

79512

Class 2

Z-1328-2018

2017-12-22

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162546

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.