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
Reported: September 1, 2021 Initiated: April 26, 2021 #Z-2334-2021
Product 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 for Recall
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Details
- Recalling Firm
- Northeast Scientific Inc.
- Units Affected
- 690 devices
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
- Location
- Waterbury, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Northeast Scientific Inc.. Units affected: 690 devices.
Why was this product recalled? ▼
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2334-2021.
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