Z-2334-2021 Class II Terminated
FDA device recall Z-2334-2021 was initiated by Northeast Scientific Inc. on Apr 26, 2021 and is designated Class II. Reason for recall: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. The recall status is terminated (terminated Mar 9, 2022). Affected quantity: 690 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 1, 2021
- Initiation Date
- Apr 26, 2021
- Termination Date
- Mar 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 690 devices
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.
Distribution Pattern
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, NC, NJ, NY, TX.
Code Information
Lots L0017886 through L0020553