Class 2 Device Recall CIVCO lnfiniti Needle Guide Bracket.

• Date Initiated by Firm: February 23, 2018
• Create Date: August 22, 2018
• Recall Status: Terminated on October 06, 2020
• Recall Number: Z-2888-2018
• Recall Event ID: 80704
• 510(K)Number: K093713
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. ; ; Product Usage:; The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
• Code Information: Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110, M119380, M605540, M706720, M570610, M543670, M851530, M983170, M358570. M358570, M427660. M526300, M526300, M734570, M912740, and M664690. Item 698-009: Biopsy Starter Kit for use with Zonare C9-3 transducers M427370, M103030, A010473, M103030, M771190, M427390, M293590, M427370, M105150, M089260, M515370, M293580, M888920, M427370, M220960, M558420, M560740, M909270, M096330, M388690, M558220, M695400, M085550, M917410, M419650, M879530, M964370, M093020, M723180, and A010459 Item: 698-016 Biposy Bracket for use with Zonare C9-3 transducers M567620 and M052860 Item 620-116 Biopsy Starter Kit for use with BK Medical 18L5 and 8870 transducers M080890, M559550, M425050, M056610, M092800, M041630, M186540, M122250, M335740, M043310, M499390, M483250, M109060, M275630, M912150, A023904, M457560, M051670, M091360, M895560, A015235, M202260, M869430, M056610, M027090, M308820, M831280, M547370, M253050, M083160, and M865470
• Recalling Firm/ Manufacturer: Civco Medical Instruments Co. Inc.; 102 1st St S; Kalona IA 52247-9589
• For Additional Information Contact: 319-248-6500
• Manufacturer Reason for Recall: A cover failed leak testing during validation testing of new needle guides from a replacement tool.
• FDA Determined Cause: Device Design
• Action: Telephone Script to be read: CIVCO is calling to notify our customers regarding a recall action being initiated. CIVCO has recently discovered a dimensional issue in our Infiniti bracket which may allow the needle guide to a puncture a cover. You are being notified, as your facility has been identified as having received product from one of the affected manufacturing lots. Advise on Action to be taken by Customer or Distributor: To return Infiniti needle guide, contact your Account Representative at 800-445-6741 or 319-248-6757. Alternately you may also use email at order@civco.com to schedule the return of your device. Additional information to obtain: Verification of Email contact to send notification letter and response letter.
• Quantity in Commerce: 177 boxes
• Distribution: Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada
• 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