FDA Device recall Z-1218-2015
TriaDyne Proventa Critical Care Therapy System
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of TriaDyne Proventa Critical Care Therapy System by Arjo Hospital Equipment Ab, citing the recalled devices labeling and instructions for use contain unapproved medical claims.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1218-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjo Hospital Equipment Ab |
| Distribution | US |
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.
Identifiers
| code_info | SERIAL NUMBERS: TDBK00046 TDBK00096 TDDK00006 TDDK00008 TDDK00122 TDDK00126 TDDK00254 TDBK00281 TDDK00265 TD…SERIAL NUMBERS: TDBK00046 TDBK00096 TDDK00006 TDDK00008 TDDK00122 TDDK00126 TDDK00254 TDBK00281 TDDK00265 TDBK00292 TDBK00134 TDDK00036 TDDK00149 TDDK00363 TDBK00323 TDBK00355 TDBK00370 TDDK00035 TDDK00066 TDBK00348 TDBK00360 TDDK00184 TDDK00242 TDGK00116 TDGK00117 TDGK00123 TDBK00049 TDGK00024 TDDK00118 TDBK00349 TDDK00021 TDDK00245 TDBK00033 TDBK00250 TDBK00320 TDDK00054 TDDK00158 TDDK00224 TDGK00026 TDGK00032 TDBK00070 TDDK00062 TDDK00231 TDDK00278 TDBK00131 TDBK00284 TDBK00319 TDBK00367 TDDK00121 TDDK00255 TDDK00285 TDBK00058 TDBK00280 TDDK00202 TDDK00217 TDDK00005 TDDK00155 TDDK00183 TDDK00252 TDDK00269 TDBK00099 TDBK00339 TDDK00268 TDDK00330 TDBK00306 TDBK00253 TDBK00271 TDDK00082 TDDK00084 TDDK00362 TDGK00004 TDGK00031 TDGK00130 TDGK00147 TDBK00379 TDDK00142 TDDK00146 TDDK00334 TDGK00019 TDGK00108 TDGK00168 TDGK00169 TDLK00010 TDLK00011 TDLK00015 TDDK00052 TDBK00301 TDBK00359 TDDK00009 TDD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1218-2015%22
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