Device Recall Excelsior Medical 의 리콜

Recall

68573

Class 2

Z-2070-2014

2014-06-05

2014-07-16

Terminated

United States

2015-08-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128242

There is a potential for a leak. a molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.

Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that it was supplied to and notify them at once of the product recall. A phone number was provided in case customers had questions regarding the recall (1.800.487.4276 8:30 am - 5:00 pm EST) as well as an email address (recall12@excelsiormedical.com).