RenovoCath RC 120 Catheter Recalled for Incorrect Instructions for Use
RenovoRx, Inc. is recalling 11 units of the RenovoCath RC 120 Temporary Intravascular Occluding Catheter because incorrect Instructions for Use were shipped to customers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but involves a documentation error (incorrect Instructions for Use) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
RenovoRx, Inc. is recalling 11 units of the RenovoCath RC 120 Temporary Intravascular Occluding Catheter, model number MMRC120-DB-1111. The recall was initiated because incorrect versions of the Instructions for Use (IFU) were shipped to two US customers.
The affected units are identified by Lot number B2456974A with an expiry date of 2016-07. The product was distributed in the United States to the states of California and Florida. The RenovoCath RC 120 is a prescription-only medical device intended for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system.
The FDA has classified this recall as Class II, which means the product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text. Users should contact RenovoRx, Inc. for further instructions regarding the replacement of the correct Instructions for Use.
The recalled product
- 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…
- Manufacturer
- RenovoRx, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model number: MMRC120-DB-1111
- Lot number: B2456974A
Distribution
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