| Class 2 Device Recall CIVCO Needle Guide | |
Date Initiated by Firm | July 30, 2018 |
Create Date | August 29, 2018 |
Recall Status1 |
Terminated 3 on September 16, 2020 |
Recall Number | Z-2946-2018 |
Recall Event ID |
80656 |
510(K)Number | K970514 |
Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
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Product | CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO |
Code Information |
UDI 00841436107327, Lot numbers: A018067, A018067, A021026, A021026, A021226, A021226, A021226, A022447, A022447, A023876, A023876, A025137, A025137, A025137, A025137, A02560, A025606, A025606, A025606, A026609, A026609, A026609, A026609, A026610, A026610, A026610, A028159, A028159, A028645, A029293, A029293, A029293, A029383, A032036, A032036, A032036, A032036, A032036, A032036, A033139, A033139, A033139, A033139, A033153, A033153, A035009, A035009, A035009, A035010, A035010, A035010, A035010, A035010, A035568, A035568, A037150, A037231, A037231, A037231, A037585, A037585, A039417, A039417, A040376, A040376, A040839, A041444, A041444, A041444, A041723, A041723 |
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 |
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 | 107 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
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