Northeast Scientific recalls NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter (R-410-154) due to potential sterile packaging breaches. This could compromise sterility during medical procedures.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific is recalling a specific laser catheter model because its sterile packaging might be compromised, risking infection during medical procedures. This affects only certain medical devices used in specific treatments.
The sterile packaging could breach, allowing contaminants to enter the device. This might lead to infections during medical procedures if the device is not properly sterilized.
Healthcare professionals using this catheter for vascular treatments. Patients undergoing procedures with this device are at risk if the packaging is compromised.
Look for the model number R-410-154 on the catheter. The product was sold with expiration dates before August 29, 2026.
Verify the model number R-410-154 and expiration date before August 29, 2026.
This catheter is not cleared for marketing in the US and is only intended for specific vascular treatments under medical supervision.
The recall does not specify a remedy, so contact the manufacturer for guidance.
The hazard is potential packaging breaches that could compromise sterility, but no specific injury mechanism is described.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0022-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0022-2026 from Northeast Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
