United StatesWhat's being recalled
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. 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.
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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.
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. 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.
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. 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.
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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.
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. 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.
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.
Recalling firm: Northeast Scientific Inc., Waterbury, CT, United States.
How to identify it
Model No R-410-152; UDI-DI 00850044399055; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 Model No R-414-151; UDI-DI 00850044399116; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 Model No R-417-152; UDI-DI 00850044399093; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026 Model No R-420-006; UDI-DI 00850044399079; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. Model No R-410-154; UDI-DI 00850044399062; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. Model No R-414-159; UDI-DI 00850044399123; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. Model No R-417-156; UDI-DI 00850044399109; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026. Model No R-420-159; UDI-DI 00850044399086; All Lot Numbers that are within their labeled shelf life with expiration dates prior to 29AUG2026.
The hazard
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)