Northeast Scientific recalled 1,019 units of the 1.4mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about potential breaches in the sterile barrier packaging. The product poses a high hazard level due to compromised sterility assurance.
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
The recalled product is the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter, Model Number R-414-159. It distributed nationwide to states including CA, FL, and NY. The catheter is classified as Class II.
The recall stems from the potential for breaches in the sterile barrier packaging. This compromises the sterility assurance, which can lead to severe health risks during medical procedures.
As of the recall date, there have been no reported injuries or incidents related to this device. The potential risks remain high due to the nature of the breach.
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 detailed instructions.
For questions regarding the recall, contact Northeast Scientific Inc. directly or visit their website for further instructions.
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