Reported Sep 1, 2021 · Terminated
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood…
Northeast Scientific Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northeast Scientific Inc. · 2142 Thomaston Ave · Waterbury, CT · 06704-1013
Is this the product you have?
- 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
- Lot codes and dates
- Lots L0017886 through L0020553
- Amount recalled
- 690 devices
Where it was sold
Why it was recalled
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
This product could cause temporary or reversible health problems — stop using it.
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