| Class 2 Device Recall CIVCO Needle Guide Starter Kit | |
Date Initiated by Firm | November 02, 2018 |
Create Date | December 07, 2018 |
Recall Status1 |
Terminated 3 on November 20, 2020 |
Recall Number | Z-0570-2019 |
Recall Event ID |
81361 |
510(K)Number | K030064 |
Product Classification |
Transducer, ultrasonic, diagnostic - Product Code ITX
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Product | CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx. |
Code Information |
Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling. |
Recalling Firm/ Manufacturer |
CIVCO Medical Instruments Co., Inc. 2301 Jones Blvd Coralville IA 52241-3469
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For Additional Information Contact | Mr. James Leong 319-248-6502 |
FDA Determined Cause 2 | Other |
Action | The recalling firm began issuing letters dated 10/30/2918 via email on 11/2/2018 requesting return of the boxes of product or reusable brackets that may be in their inventory. |
Quantity in Commerce | 66 boxes |
Distribution | Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the 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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