Terminated

Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.

FDA Recall Z-0700-05 · Posted 2005-04-13

Recalling FirmNeoprobe Corp

Recall StatusTerminated

Product CodeDPW

Date Initiated2004-12-13

Date Terminated2007-07-21

Product Quantity64 devices

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.

Firm Action

The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030357QUANTIX/OR DEVICECardiosonix, Ltd. · 2003-08-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.