TriaDyne Proventa Critical Care Therapy System — Class II medical device recall Z-1218-2015
Terminated recall by Arjo Hospital Equipment AB, reported 2015-03-11, distributed nationwide. The recalled devices labeling and instructions for use contain unapproved medical claims.
| Recall number | Z-1218-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo Hospital Equipment AB, Malm¿, N/A, Sweden |
| Recall initiated | 2014-12-03 |
| Classified | 2015-02-27 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2015-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CN, DE, FR, IN, IT, JP, KW, MX, QA, SA |
| Quantity | 567 units |
| Reason classes | labeling, unapproved product |
| Serial numbers | TDBK00012, TDBK00021, TDBK00028, TDBK00030, TDBK00033, TDBK00036, TDBK00038, TDBK00039, TDBK00041, TDBK00043, TDBK00045, TDBK00046, TDBK00049, TDBK00050, TDBK00052, TDBK00053, TDBK00057, TDBK00058, TDBK00060, TDBK00061, TDBK00062, TDBK00064, TDBK00067, TDBK00068, TDBK00070 and 475 more |
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 for recall
The recalled devices labeling and instructions for use contain unapproved medical claims.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1218-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.