Northeast Scientific recalls 1.4mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-414-151) 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 type of laser catheter used in medical procedures because its sterile packaging might be compromised. This could lead to infections if the device is used without proper sterility.
The sterile packaging might develop breaches during storage or handling, which could allow contamination. This compromises the device's sterility assurance, potentially leading to infections during medical procedures.
Medical professionals who use this catheter for treating leg blockages may be affected. Patients undergoing procedures with this device could face infection risks if sterility is compromised.
Look for the model number R-414-151 on the catheter. The device was sold with expiration dates before August 29, 2026. This specific catheter is not approved for use in the US.
Verify the model number R-414-151 and expiration date before August 29, 2026.
No, this model is not cleared for marketing in the US.
Potential breaches in the sterile packaging could compromise sterility, leading to infection risks during medical procedures.
Look for the model number R-414-151 with an expiration date before August 29, 2026.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0019-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0019-2026 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.
