Northeast Scientific recalled 141 units of the 2.0mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall stems from potential breaches in the sterile barrier packaging, risking patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Northeast Scientific Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter, Model Number R-420-159. It is classified as a Class II medical device. The product was distributed nationwide in the U.S. to multiple states.
The recall addresses a potential breach in the sterile barrier packaging. This compromises the sterility assurance of the device, increasing the risk of infection or other complications.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the potential for compromising sterility.
Stop using the device immediately. Follow the recall instructions provided by Northeast Scientific Inc. Contact your healthcare provider for further guidance.
For more information, contact Northeast Scientific Inc. Visit the FDA recall page for details at: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0025-2026.
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