Northeast Scientific recalls NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter (Model R-420-159) 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 their Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter (Model R-4:420-159) because the sterile packaging might be compromised. This could lead to infections during medical procedures if the catheter is used without proper sterility.
The sterile packaging could be breached, which might allow contamination. This could lead to infections during medical procedures if the catheter is not properly sterilized.
Medical professionals who use this catheter for treating leg blockages. Patients undergoing procedures with this device are at risk of infection if sterility is compromised.
Check for the model number R-420-159 on the catheter. The product 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, so it should not be used until the issue is resolved.
Check the packaging for damage and contact Northeast Scientific for guidance on next steps.
The recall focuses on sterility risks, not direct injury, so the danger level is low risk.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0025-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0025-2026 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.