Northeast Scientific recalled 165 units of the Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall stems from potential breaches in the sterile barrier packaging. This defect compromises sterility assurance and poses 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 OTW Turbo Elite Laser Atherectomy Catheter, Model Number R-417-152. It is not cleared for marketing in the U.S. The product was distributed nationwide to states including California, Florida, Illinois, and Texas.
The recall addresses potential breaches in the sterile barrier packaging of the device. This risk could compromise sterility assurance, leading to severe health implications for patients.
There are no reported injuries or incidents directly associated with this recall. However, the risk of infection due to compromised sterility is significant.
Patients and healthcare providers must stop using the device immediately. Follow the manufacturer's recall instructions and contact Northeast Scientific Inc. or your healthcare provider for further instructions.
For more information, contact Northeast Scientific Inc. at the provided link. Visit the FDA's recall page for additional details.
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