Northeast Scientific recalled 199 units of its Laser Atherectomy Catheter on August 29, 2025. The recall follows a risk of breaches in the sterile barrier packaging, compromising sterility. Patients and healthcare providers must stop using the device immediately.
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 OTW Turbo Elite Laser Atherectomy Catheter, Model Number R-420-006. The product was distributed nationwide in the United States, specifically to states including California, Florida, and Texas. It is classified as a Class II medical device.
The recall stems from a potential for breaches in the sterile barrier packaging. This issue compromises the sterility assurance of the catheter, posing a risk to patients.
No incidents or injuries have been reported related to this recall. The risk remains high due to the potential for compromised sterility.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by Northeast Scientific Inc. Contact them or your healthcare provider for further instructions.
For more information, contact Northeast Scientific Inc. at 1-800-XXX-XXXX. Additional details are available at their official website.
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