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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO Tracking Bracket Starter Kit

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  Class 2 Device Recall CIVCO Tracking Bracket Starter Kit see related information
Date Initiated by Firm October 21, 2015
Date Posted November 17, 2015
Recall Status1 Terminated 3 on February 28, 2017
Recall Number Z-0289-2016
Recall Event ID 72378
510(K)Number K093713  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Code Information M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150
Recalling Firm/
Manufacturer		 Civco Medical Instruments Co. Inc.
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-248-6502
Manufacturer Reason
for Recall		 Sterility of the product cannot be assured.
FDA Determined
Cause 2		 Process design
Action Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type of affected product they are returning. Customers withh questions were instructed to call 800-445-6741 or 319-248-6757 or email order@civco.com. For questions regarding this recall call 319-248-6502.
Quantity in Commerce 206 boxes
Distribution Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, 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
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