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

Recall Z-1012-2015 — Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

U.S. FDA — Device Enforcement · United States · 2014-12-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1012-2015
Date of alert: 2014-12-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Aesculap, Inc.
Product category: device
Product type: Devices

Reported risk: Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).

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.

Recall Z-1012-2015 — Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

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