United StatesParadise Ultrasound Renal Denervation System catheter (Paradise Catheter, model PRDS-068-02; UDI-DI 00810008950043; Lot numbers M4907 and M4862) is affected. ReCor Medical recalled these devices because the firm distributed a nonconforming product that was supposed to be scrapped and not for human use; affected units were distributed in CA, CO, FL, KS, MO, NC, OH, TX, and VA.
What's being recalled
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Recalling firm: ReCor Medical Inc., Palo Alto, CA, United States.
How to identify it
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907 Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
The hazard
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)