Northgate Technologies recalls their AUTOLITH URO-TCH 9FR 54cm probe (NTI Catalog 9-203-0543) due to failed biocompatibility testing. This could pose health risks during medical use.
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Northgate Technologies is recalling their AUTOLITH URO-TCH 9FR 54cm probe because it failed biocompatibility testing. This means the probe might not be safe for medical use, potentially causing health issues during procedures.
The probe failed biocompatibility testing, meaning it may not be safe for contact with the body. This could lead to health issues during medical procedures if used without proper safety checks.
Medical professionals who use this probe for urinary/renal or biliary procedures are likely affected. Patients undergoing these procedures with the recalled probe are at risk.
Check for the NTI Catalog Number 9-203-0543 on the probe. This product is used for fragmenting urinary/renal and biliary calculi in medical procedures.
Look for the NTI Catalog Number 9-203-0543 on the probe to confirm if it's recalled.
The probe failed biocompatibility testing, which means it may not be safe for medical use.
The recall record does not specify a remedy, so check with Northgate Technologies for further instructions.
The recall indicates it failed biocompatibility testing, so it is not considered safe for medical use.
We’ve drafted a message you can send Northgate Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-1884-2020 — Northgate Technologies Northgate Technologies Hello, I own a Northgate Technologies that is covered by recall Z-1884-2020 from Northgate Technologies. 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.
