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U.S. Department of Health and Human Services

Class 2 Device Recall Quantix/Or Ultrasound Probe

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  Class 2 Device Recall Quantix/Or Ultrasound Probe see related information
Date Initiated by Firm December 13, 2004
Date Posted April 13, 2005
Recall Status1 Terminated 3 on July 21, 2007
Recall Number Z-0701-05
Recall Event ID 30795
510(K)Number K030357  
Product Classification Flowmeter, Blood, Cardiovascular - Product Code DPW
Product Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
Code Information All serial numbers.
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 2		 Other
Action The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.
Quantity in Commerce 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.
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 and Original Applicant = CARDIOSONIX, LTD.
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