FDA Medical Device Recalls (openFDA)
Neoprobe Corp: Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
- Recall number
- Z-0701-05
- Recalling firm
- Neoprobe Corp
- Product
- Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
- Status
- Terminated
- Initiated
- 2004-12-13
- Posted
- 2005-04-13
- Terminated
- 2007-07-21
- Reason
- 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.
- Root cause
- Other
- Action
- The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.
- Quantity
- 19 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.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K030357"]
- PMA numbers
- not on file
- Product code
- DPW
- Firm FEI
- 3009548429
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28