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

Recall Z-0397-2014 — CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts

U.S. FDA — Device Enforcement · United States · 2013-11-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0397-2014
Date of alert: 2013-11-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Neurosurgery
Product category: device
Product type: Devices

Reported risk: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

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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