Northeast Scientific recalls NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter (Model R-420-006) due to potential sterile packaging breaches. Affected units have expiration dates before August 29, 2026.
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific is recalling a specific type of medical catheter that may have compromised sterile packaging. This could lead to infections if used improperly. The recall affects units with expiration dates before August 29, 2026.
The sterile packaging could be breached, leading to contamination of the catheter. This might cause infections if the catheter is used without proper sterility assurance.
Healthcare professionals using this catheter for vascular procedures are most at risk. Patients receiving the catheter during procedures may be affected if the sterile packaging is compromised.
Check for the model number R-420-006 on the catheter packaging. Units with expiration dates before August 29, 2026 are affected.
Verify the expiration date on the packaging; units with dates before August 29, 2026 are affected.
The recall indicates potential packaging issues, but the catheter is not cleared for US marketing. Use only units with expiration dates after August 29, 2026.
The sterile packaging may be breached, compromising sterility assurance and potentially causing infections.
Look for model number R-420-006 with expiration dates before August 29, 2026 on the packaging.
We’ve drafted a message you can send Northeast Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0021-2026 — Northeast Scientific Northeast Scientific Hello, I own a Northeast Scientific that is covered by recall Z-0021-2026 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.
