FDA Medical Device Recalls (openFDA)
Natus Manufacturing Limited: 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.
- Recall number
- Z-1143-2021
- Recalling firm
- Natus Manufacturing Limited
- 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.
- Status
- Terminated
- Initiated
- 2021-01-12
- Posted
- not on file
- Terminated
- 2022-11-08
- Reason
- The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- On January 12, 2021, Natus sent an "Urgent Field Safety Notice - Recall" notification to all affected consignees via US Mail. In addition to informing consignees about the recall, the notification asked consignees to take the following actions: 1. Please return these affected items at your earliest convenience to the following address: 3150 Pleasant View Road, Middleton, WI 53562 USA 2. Replacement product is available. The Technical Service department will be in contact in relation to the provision of the replacement product. 3. Please complete and return the customer reply form to Natus at the following Email address: FCA@Natus.com
- Quantity
- 7 units
- Distribution
- US Nationwide distribution in the state of NY.
- Lot, serial or model codes
- Lot # 118000422298
- 510(k) numbers
- ["K162437"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3005581270
- Firm city
- Galway
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28