NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood ves
Summary
The FDA issued a Class II for NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evalua by Northeast Scientific Inc.. Reason: 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles..
Details
Source
Device Recall
External ID
Z-2334-2021
Action Date
2021-09-01
Status
Terminated
Category
device
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
Lot/Code Info: Lots L0017886 through L0020553
Quantity Affected: 690 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-26
Company
Waterbury, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Northeast Scientific Inc. has 12 FDA actions in our database, including 9 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Northeast Scientific Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Northeast Scientific Inc. have FDA actions?
Northeast Scientific Inc. has 12 FDA actions in our database, including 9 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2334-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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