Class 2 Device Recall Quantix/Or Ultrasound Probe

• Date Initiated by Firm: December 13, 2004
• Date Posted: April 13, 2005
• Recall Status: Terminated on July 21, 2007
• Recall Number: Z-0700-05
• Recall Event ID: 30795
• 510(K)Number: K030357
• Product Classification: Flowmeter, Blood, Cardiovascular - Product Code DPW
• Product: Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.
• Code Information: All serial numbers.
• FEI Number: 3009548429
• Recalling Firm/ Manufacturer: Neoprobe Corp; 425 Metro Pl N Ste 300; Dublin OH 43017-1367
• For Additional Information Contact: Rodger A. Brown; 614-822-2342
• Manufacturer Reason for Recall: The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
• FDA Determined Cause: Other
• Action: The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.
• Quantity in Commerce: 64 devices
• Distribution: Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.
• 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 = DPW