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
This recall has been terminated (originally issued April 26, 2021).
- Company
- Northeast Scientific Inc.
- Recall Initiated
- April 26, 2021
- Terminated
- March 9, 2022
- Recall Number
- Z-2334-2021
- Quantity
- 690 devices
- Firm Location
- Waterbury, CT
- Official Source
- View on FDA website ↗
Reason for Recall
510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Distribution
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Lot / Code Info
Lots L0017886 through L0020553
Root Cause
No Marketing Application
Action Taken
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.
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