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Arjo Hospital Equipment AB recalls TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a compreh
Recalled March 11, 2015 · FDA recall Z-1218-2015 · Arjo Hospital Equipment AB
Hazard
The recalled devices labeling and instructions for use contain unapproved medical claims. · FDA Class II
Units
567 units
Sold at
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
Description
The recalled devices labeling and instructions for use contain unapproved medical claims.
Product
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.
Manufacturer(s)
Arjo Hospital Equipment AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →