UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Adva

FDA device recall Z-1174-2010 · posted 2010-03-19 · Terminated

Recall details

Recalling firm

Urologix, Inc.

Reason for recall

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

Action taken

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

MEQ

Quantity affected

154

Distribution

AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.

Date initiated

2010-02-18

Date posted

2010-03-19

Date terminated

2012-03-08

Location

Minneapolis, MN