Z-0700-05

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

Name: Z-0700-05 Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system
Creator: Neoprobe Corp
Published: 2004-12-13
License: https://open.fda.gov/license/

Neoprobe Corp. / initiated 2004-12-13 / Terminated

FDA source

Neoprobe Corp began a recall of Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system on 2004-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0700-05
Status: Terminated
Initiated: 2004-12-13
Posted: 2005-04-13
Terminated: 2007-07-21
Recalling firm: Neoprobe Corp.
Product: Product is CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system.
Product code: DPW Flowmeter, Blood, Cardiovascular
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 root 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.
Product codes and lots: All serial numbers.

Product code DPW

K030357Class IIQuantix/or DeviceCardiosonix, Ltd. / cleared 2003-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)