Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

MVP-10 Pediatric/ Neonatal Volume Ventilator

FDA Recall Z-0300-04 · Posted 2004-01-06

Recalling FirmBio-Med Devices, Inc.
Recall StatusTerminated
Product CodeMNT
Date Initiated2003-11-07
Date Terminated2016-02-01
Product Quantity3 units

Reason for Recall

Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.

Firm Action

Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.

Root Cause

Other

Distribution Pattern

ID, PA, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑