The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1218-2015·Announced 2015-03-11

Arjo TriaDyne Proventa Critical Care Therapy System Recalled for Unapproved Claims

Arjo Hospital Equipment AB is recalling 567 TriaDyne Proventa Critical Care Therapy Systems because their labeling and instructions for use contain unapproved medical claims.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as unapproved medical claims in labeling rather than a physical defect or reported injury, aligning with the rubric for minor labeling errors.

Plain-English summary

Arjo Hospital Equipment AB is recalling 567 units of the TriaDyne Proventa Critical Care Therapy System. This system provides pulmonary and skin care therapies for critically ill, immobilized patients.

The recall was initiated because the labeling and instructions for use for these devices contain unapproved medical claims. The agency has classified this as a Class II recall.

The affected units were distributed worldwide, including in the United States, Germany, Austria, France, Italy, India, the EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, the Middle East, China, Japan, and Qatar. Specific serial numbers for the affected units are listed in the official recall record.

The recalled product

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
Arjo Hospital Equipment AB
Category
Medical Device — Critical Care Therapy
Hazard
Affected units
567

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Arjo Hospital Equipment AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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