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Class 2 Device Recall CIVCO Needle Guide |
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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
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Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
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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
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For Additional Information Contact |
319-248-6500
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = ITX and Original Applicant = CIVCO MEDICAL INSTRUMENTS CO., INC.
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