Northeast Scientific recalls NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-417-152) 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 1.7mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-417-152) because the sterile packaging might be compromised, risking infection during medical procedures. This recall affects units with expiration dates before August 29, 2026.
The sterile packaging may develop breaches that compromise the device's sterility, potentially leading to infections during medical procedures. This is a risk specific to the reprocessed version of the catheter.
Medical professionals using this catheter for vascular procedures are most at risk. Patients receiving this device during surgery could face infection if the sterile packaging is breached.
Check for the model number R-417-152 on the packaging. The catheter was sold with expiration dates before August 29, 2026.
Verify the expiration date on the packaging; units with dates before August 29, 2026 are affected.
The recall indicates potential packaging issues that could compromise sterility, so affected units should not be used until the remedy is applied.
Check the expiration date on the packaging. If it expires before August 29, 2026, contact Northeast Scientific for guidance.
The sterile packaging may have breaches that could compromise the device's sterility, risking infections during medical procedures.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0020-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0020-2026 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.
