Natus recalls EDS 3 CSF External Drainage Systems due to potential endotoxin contamination in cerebrospinal fluid drainage. Affected units may pose health risks requiring medical evaluation.
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Natus is recalling its EDS 3 CSF External Drainage Systems because they failed pyrogen tests, meaning they could contain harmful endotoxins that might affect cerebrospinal fluid. This is serious for patients using the device for spinal fluid drainage.
The drainage system failed to meet pyrogen test standards, which means it could contain endotoxins. Endotoxins are bacterial components that can cause infections or inflammation in the cerebrospinal fluid, potentially leading to serious health issues.
Patients using the Natus EDS 3 CSF External Drainage System for cerebrospinal fluid drainage are affected. Those with medical implants or ongoing treatment are at highest risk.
Check for the model 'EDS 3 CSF External Drainage System' with lot number 118000422298. The product is used for draining cerebrospinal fluid to reduce pressure in the brain.
Immediately discontinue use of the Natus EDS 3 CSF External Drainage System if you have it.
The external drainage system failed pyrogen tests, meaning it could contain harmful endotoxins that might affect cerebrospinal fluid.
Stop using it immediately and contact your healthcare provider for medical evaluation.
The recall record does not mention a remedy or replacement option.
We’ve drafted a message you can send Natus to request your refund or repair — edit it as you like.
Subject: Recall Z-1143-2021 — Natus Natus Hello, I own a Natus that is covered by recall Z-1143-2021 from Natus. 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.
