Recall Z-2334-2021 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Northeast Scientific Inc.
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
| Date | Apr 26, 2021 |
| Status | Terminated |
| Reason | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. |
| Root cause | No Marketing Application |
| 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. |
| Quantity | 690 devices |
| Distribution | US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.