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U.S. Department of Health and Human Services

Class 3 Device Recall CIVCO LatexFree Needle Guide

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  Class 3 Device Recall CIVCO LatexFree Needle Guide see related information
Date Initiated by Firm January 16, 2008
Date Posted March 19, 2008
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = CIVCO MEDICAL INSTRUMENTS CO., INC.
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