FDA Recall
Terminated
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Recall: Z-2334-2021
·
Initiated April 26, 2021
Recall
- Recall Number
- Z-2334-2021
- Event Number
- 88345
- Firm
- Northeast Scientific Inc.
- FEI Number
- 3005467144
- Product Code
- OWQ
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- April 26, 2021
- Terminated
- March 9, 2022
- Address
- 2142 Thomaston Ave, Waterbury, CT, 06704-1013
Description
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901
Reason
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Action
Northeast Science contacted customers by telephone and email on 4/26/21. Customers were asked if inventory remained of the affected lot numbers. Had any of the customers had inventory they would have been instructed to return the products. No inventory was found of the affected lots.
Distribution
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Quantity
690 devices