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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Needle Guide

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  Class 2 Device Recall CIVCO Needle Guide see related information
Date Initiated by Firm July 30, 2018
Create Date August 29, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-2947-2018
Recall Event ID 80656
510(K)Number K970514  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Code Information UDI 00841436107334, Lot numbers: A035054, A042207 
Recalling Firm/
Manufacturer		 Civco Medical Instruments Co. Inc.
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact
319-248-6500
Manufacturer Reason
for Recall		 The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
FDA Determined
Cause 2		 Process control
Action The firm initiated communication on 07/30/2018 by email and telephone calls. The firm requested return of the recalled product. Questions may be made to the Account Representative by calling CIVCO Medical Solutions, Multi-Modality Imaging at 800-445-6741 or 319-248-6757 7:00 AM - 5:30 PM CST or by email at order@civco.com
Quantity in Commerce 3 units
Distribution United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
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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