Arjo Hospital Equipment AB TriaDyne Proventa Critical Care Therapy System recall — FDA Z-1218-2015
The recalled devices labeling and instructions for use contain unapproved medical claims.
Overview of recall records associated with Arjo Hospital Equipment AB, including dates, categories and classifications where available.
Classification mix: Class II: 3.
The recalled devices labeling and instructions for use contain unapproved medical claims.
The recalled devices labeling and instructions for use contain unapproved medical claims.
The recalled devices labeling and instructions for use contain unapproved medical claims.
This page summarizes recall records in which the official source identifies Arjo Hospital Equipment AB as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.