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

Recall Z-1210-2017 — Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous bloo

U.S. FDA — Device Enforcement · United States · 2016-12-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1210-2017
Date of alert: 2016-12-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atrium Medical Corporation
Product category: device
Product type: Devices

Reported risk: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

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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