NES Reprocessed Visions PV .035 IVUS Catheter recall
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral…
Why was NES Reprocessed Visions PV .035 IVUS Catheter recalled?
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
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?
Lots L0017886 through L0020553
- Product
- NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral…
- Recalling firm
- Northeast Scientific Inc.
- Quantity
- 690 devices
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)