NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy recall: Sterility Concern
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter…
Why was NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy recalled?
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No R-420-006; UDI-DI 00850044399079; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
- Product
- NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter…
- Recalling firm
- Northeast Scientific Inc.
- Quantity
- 199 units
- Distribution
- US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
- Recall date
- October 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)