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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Biopsy Bracket

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  Class 2 Device Recall CIVCO Biopsy Bracket see related information
Date Initiated by Firm November 02, 2018
Create Date December 07, 2018
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-0565-2019
Recall Event ID 81361
510(K)Number K030064  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
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
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 73 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
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 = SONOSITE,INC.
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