Northeast Scientific recalls NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter (Model R-417-156) due to potential sterile packaging breaches. Affected units sold with expiration dates before August 29, 2026.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific is recalling its reprocessed laser atherectomy catheter (Model R-417-156) because the sterile packaging might be compromised. This could lead to infections during medical procedures if the device is used without proper sterility.
The sterile packaging may have breaches that compromise the device's sterility. If the packaging is not intact, the catheter could cause infections during medical procedures.
Healthcare professionals using this catheter for vascular procedures are most at risk. Patients receiving the device during procedures could face infection if the sterile packaging is breached.
Check for the model number R-417-156 on the packaging. The device was sold with expiration dates before August 29, 2026.
Inspect the sterile packaging for any signs of damage or breaches.
The recall indicates potential packaging breaches that could compromise sterility. Do not use the device until the packaging is confirmed intact.
The device expires before August 29, 2026, as stated in the recall notice.
The recall does not provide a remedy, so users should check packaging integrity and contact the manufacturer if concerns arise.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0024-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0024-2026 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.
