NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-E
Summary
The FDA issued a Class II for NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R by Northeast Scientific Inc.. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance..
Details
Source
Device Recall
External ID
Z-0025-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US.
Lot/Code Info: Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
Quantity Affected: 141 units
Reason for Recall
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Distribution
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-29
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 168 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-0025-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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