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 |
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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.
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510(K) Database | 510(K)s with Product Code = MJN
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