Natus EDS 3 CSF External Drainage System Recalled for Pyrogen Test Failure
Natus Manufacturing Limited is recalling 7 units of the EDS 3 CSF External Drainage System because the device failed to meet pyrogen test requirements for endotoxins.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device contacting cerebrospinal fluid that failed pyrogen/endotoxin tests, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Natus Manufacturing Limited is recalling 7 units of the Natus EDS 3 CSF External Drainage System, reference number NT821731C. The product is indicated for draining cerebrospinal fluid from the cerebral ventricles or the lumbar subarachnoid space to reduce intracranial pressure and CSF volume when a permanent internal shunt is not indicated.
The recall was initiated because the external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid, specifically regarding 2.15 endotoxins. The affected units are identified by Lot # 118000422298. The distribution pattern is listed as US Nationwide distribution in the state of NY.
Healthcare providers and facilities should stop using the affected devices and contact Natus Manufacturing Limited for further instructions on the recall.
The recalled product
- Product
- Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a…
- Manufacturer
- Natus Manufacturing Limited
- Category
- Medical Device — Neurological
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 118000422298
Distribution
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