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.
Urolgix¿ is recalling certain lots of ctc advance" catheters and rtu plus devices which are integral components of the targis¿ system. the reason for this recall is a labeling error only; the issue involves a discrepancy in the"use before" date printed on the product label. in the affected lots, the "use before" date , commonly known as the expiration date, is printed as 2012-12 when it should r.
조치
Consignees were sent a UROLOGIX " Important Recall Information" letter dated February 18, 2010. The letter was addressed to the client's name. The letter described the problem and product involved. It provided Instructions for "Returning and Replacing Affected Product" and requested the return of the "Customer Acknowledgement Form".
If you have questions, please call (763)-475-1400.
AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.
제품 설명
UROLOGIX¿ CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX¿, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. || The CTC Advance" catheters and RTU Plus are used as part of the Targis¿ System. || Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.