Recall Z-1218-2015— Arjo Hospital Equipment AB
Class II · Terminated
Class II FDA medical device recall by Arjo Hospital Equipment AB, initiated 2014-12-03, terminated 2015-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The recalled devices labeling and instructions for use contain unapproved medical claims..
- Recalling firm
- Arjo Hospital Equipment AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-03
- Terminated
- 2015-10-30
- Firm location
- Malm¿, N/A, Sweden
Product description
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.
Reason for recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
Data sourced from openFDA. This site is unofficial and independent of the FDA.