Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is n

U.S. FDA — Device Enforcement · Ireland · 2021-01-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1143-2021
Date of alert: 2021-01-12
Country / jurisdiction: Ireland
Risk level: Class II
Risk type: recall
Brand: Natus Manufacturing Limited
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 118000422298

Reported risk: The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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