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 permanent, internal shunt is not indicated.
Reported: March 3, 2021 Initiated: January 12, 2021 #Z-1143-2021
Product Description
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 permanent, internal shunt is not indicated.
Reason for Recall
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Details
- Recalling Firm
- Natus Manufacturing Limited
- Units Affected
- 7 units
- Distribution
- US Nationwide distribution in the state of NY.
- Location
- Galway, N/A
Frequently Asked Questions
What product was recalled? ▼
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 permanent, internal shunt is not indicated.. Recalled by Natus Manufacturing Limited. Units affected: 7 units.
Why was this product recalled? ▼
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1143-2021.
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