Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RenovoCath R120 Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall RenovoCath R120 Catheter see related information
Date Initiated by Firm November 25, 2015
Date Posted December 31, 2015
Recall Status1 Terminated 3 on February 29, 2016
Recall Number Z-0565-2016
Recall Event ID 72810
510(K)Number K141175  
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
Product RenovoCath RC 120;
Temporary Intravascular Occluding Catheter
Model number: MMRC120-DB-1111;
Rx only.

Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
Code Information Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.
Recalling Firm/
Manufacturer		 RenovoRx, Inc.
4546 El Camino Real Ste 282
Los Altos CA 94022-1068
For Additional Information Contact Ron Warren
650-284-4433
Manufacturer Reason
for Recall		 Incorrect version of Instructions for Use were shipped to two US customers.
FDA Determined
Cause 2		 Labeling Change Control
Action RenovoRx notified customers by phone and by mail of this issue. This notification requests that the customers remove the affected product from their inventory and remove and replace the incorrect Instructions for Use with the correct Instructions for Use provided by RenovoRx. The customers are requested to return the incorrect Instruction for Use to RenovoRx for disposition and are requested to complete a Recall Confirmation Form enclosed to document the completion of the requested Correction. For further questions, please call (650) 284-4433.
Quantity in Commerce 11 units
Distribution US Distribution to the states of : CA and FL.
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 = MJN and Original Applicant = RENOVORX, INC.
-
-