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

Recall Z-1218-2015 — TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

U.S. FDA — Device Enforcement · Sweden · 2014-12-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1218-2015
Date of alert: 2014-12-03
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: Arjo Hospital Equipment AB
Product category: device
Product type: Devices

Reported risk: The recalled devices labeling and instructions for use contain unapproved medical claims.

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-1218-2015 — TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

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