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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72810

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 25, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RenovoRx, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0565-2016
Recall number
Z-0565-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Recalling firm
RenovoRx, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect version of Instructions for Use were shipped to two US customers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect version of Instructions for Use were shipped to two US customers.

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.

Distribution pattern

US Distribution to the states of : CA and FL.