Z-0565-2016Class II

RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only...

Name: Z-0565-2016 RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only...
Creator: RenovoRx, Inc.
Published: 2015-11-25
License: https://open.fda.gov/license/

RenovoRx, Inc. / initiated 2015-11-25 / Terminated / root cause: labeling and UDI

FDA source

RenovoRx, Inc. began a recall of RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended... on 2015-11-25. FDA classified it as Class II and gives the reason as "Incorrect version of Instructions for Use were shipped to two US customers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0565-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Posted: 2015-12-31
Terminated: 2016-02-29
Recalling firm: RenovoRx, Inc.
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.
Product code: MJN Catheter, Intravascular Occluding, Temporary
Reason for recall: Incorrect version of Instructions for Use were shipped to two US customers.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0565-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0565-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31

Product code MJN

K141175Class IIRenovocath Rc120Renovorx, Inc. / cleared 2014-10-24

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)