Z-1143-2021 Class II Terminated
FDA device recall Z-1143-2021 was initiated by Natus Manufacturing Limited on January 12, 2021 and is designated Class II. Reason for recall: The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. The recall status is terminated (terminated November 8, 2022). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 12, 2021
- Termination Date
- November 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
Lot # 118000422298