Natus Medical recalls EDS 3 CSF External Drainage Systems with incomplete bioburden testing, risking infection. Affected units have specific UDI and lot numbers. Stop using immediately.
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
Natus Medical is recalling its EDS 3 CSF External Drainage System due to incomplete bioburden testing, which could compromise sterility and lead to infections. Patients using this device should stop using it immediately to avoid potential infections.
The drainage system may not be sterile because of incomplete bioburden testing during manufacturing. This could lead to infections in patients who require the device for medical treatment, especially those with compromised immune systems.
Patients with spinal cord injury or other conditions requiring CSF drainage who own the recalled EDS 3 system. Those using the device without proper sterility assurance are at highest risk.
Check for the product name 'EDS 3 CSF External Drainage System', reference number NT821731C, and sterile packaging. The unique device identifier (UDI) starts with 00382830050555 and lot numbers begin with 1FX0004588937.
Discontinue use of the EDS 3 CSF External Drainage System as it may not be sterile and could cause infection.
The recall is due to incomplete bioburden testing during manufacturing, which may compromise sterility and lead to infections.
The product is the EDS 3 CSF External Drainage System with reference number NT821731C and unique device identifier starting with 00382830050555.
Check for the reference number NT821731C and unique device identifier starting with 00382830050555 on the packaging or label.
We’ve drafted a message you can send Natus Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0635-2024 — Natus Medical Natus Medical Hello, I own a Natus Medical that is covered by recall Z-0635-2024 from Natus Medical. 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.
