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

Recall Z-2212-2013 — Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as

U.S. FDA — Device Enforcement · United States · 2013-08-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2212-2013
Date of alert: 2013-08-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zeppessis Reprocessing, LLC
Product category: device
Product type: Devices

Reported risk: Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.

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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