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

Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transport — recall Z-1352-2020

U.S. FDA — Device Enforcement · United States · 2020-01-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1352-2020
Date of alert: 2020-01-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Breas Medical, Inc.
Product category: device
Product type: Devices

Reported risk: The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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