Galway, N/A, Ireland
Natus Manufacturing Limited recalls
1 recall recorded since 2018, most recently on 12 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 12 January 2021
- Terminated
- 8 November 2022
- Reason
- The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1143-2021
- 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 intracrania
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.