Recall Z-1143-2021— Natus Manufacturing Limited
Class II · Terminated
Class II FDA medical device recall by Natus Manufacturing Limited, initiated 2021-01-12, terminated 2022-11-08. It names one FDA 510(k) clearance: K162437. 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 permanent, internal shunt is not indicated.. Reason: The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins..
- Recalling firm
- Natus Manufacturing Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-12
- Terminated
- 2022-11-08
- Firm location
- Galway, N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.