Northeast Scientific Inc. Recall 88345
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
Northeast Scientific Inc. Recall 88345 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2334-2021 |
| Event ID | 88345 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX. |
| Quantity | 690 devices |
| Recall Reason | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. |
| Device Classification | 20210901 |
| Device Code Info | Lots L0017886 through L0020553 |
| Center Classification Date | 20210823 |
| Recall Initiation Date | 20210426 |
| Recalling Firm | Northeast Scientific Inc. |
| Initial Notification | |
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