Class 3 Device Recall CIVCO LatexFree Needle Guide

• Date Initiated by Firm: January 16, 2008
• Date Posted: March 19, 2008
• Recall Status: Terminated on April 03, 2008
• Recall Number: Z-1054-2008
• Recall Event ID: 46743
• 510(K)Number: K970514
• Product Classification: Surgical Needle Guide - Product Code ITX
• Product: CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA.
• Code Information: Lot Numbers:M102250 and M105440
• FEI Number: 1937223
• Recalling Firm/ Manufacturer: Civco Medical Instruments Inc; 102 1st St S; Kalona IA 52247-9589
• For Additional Information Contact: James Leong; 319-656-4447 Ext. 224
• Manufacturer Reason for Recall: Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).
• FDA Determined Cause: Packaging
• Action: On 1/16/08, the recalling firm contacted their customers and notified them of the problem. Pictures of the problems were provided for identification. The firm requested that all products be returned.
• Quantity in Commerce: Lot M102250 - 5 boxes; Lot M105440 - 2 boxes
• Distribution: Nationwide Distribution- including states of TX and GA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ITX