Northeast Scientific recalled 616 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall affects model R-417-156 due to potential breaches in the sterile barrier packaging. This issue compromises sterility assurance, posing a high risk to patients.
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 1.7mm RX Turbo Elite Laser Atherectomy Catheter, Model Number R-417-156. The catheter was distributed nationwide in the United States, including states such as California, Florida, Illinois, and Texas. The quantity recalled is 616 units.
The product may have breaches in the sterile barrier packaging. This defect can compromise the sterility of the device, increasing the risk of infection during medical procedures.
No specific incidents or injuries have been reported related to this recall. However, the potential risk of infection due to compromised sterility is significant.
Patients and healthcare providers must stop using the catheter immediately. Follow manufacturer instructions for the recall and contact Northeast Scientific Inc. for guidance.
For more information, contact Northeast Scientific Inc. or visit the FDA's recall page at the provided URL.
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