RenovoCath RC 120 recall
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is…
Why was RenovoCath RC 120 recalled?
Incorrect version of Instructions for Use were shipped to two US customers.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is…
- Recalling firm
- RenovoRx, Inc.
- Quantity
- 11 units
- Distribution
- US Distribution to the states of : CA and FL.
- Recall date
- January 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)