TriaDyne Proventa Critical Care Therapy System
Medical device recall Z-1218-2015. Published in FDA’s Enforcement Report on Mar 11, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 11, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 567 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The recalled devices labeling and instructions for use contain unapproved medical claims.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
567 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SERIAL NUMBERS: TDBK00046 TDBK00096 TDDK00006 TDDK00008 TDDK00122 TDDK00126 TDDK00254 TDBK00281 TDDK00265 TDBK00292 TDBK00134 TDDK00036 TDDK00149 TDDK00363 TDBK00323 TDBK00355 TDBK00370 TDDK00035 TDDK00066 TDBK00348 TDBK00360 TDDK00184…
Every code shown here, 1,996 characters
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 TDDK00093 TDDK00322 TDGK00003 TDGK00007 TDDK00071 TDBK00148 TDBK00153 TDBK00272 TDBK00392 TDDK00161 TDGK00012 TDDK00365 TDBK00393 TDDK00116 TDDK00181 TDBK00361 TDDK00124 TDBK00012 TDDK00220 TDBK00097 TDGK00008 TDGK00139 TDGK00144 TDDK00018 TDDK00055 TDGK00155 TDDK00359 TDGK00115 TDDK00212 TDBK00342 TDDK00264 TDGK00118 TDBK00041 TDDK00120 TDBK00326 TDDK00298 TDDK00194 TDBK00053 TDDK00135 TDGK00153 TDLK00014 TDDK00191 TDBK00304 TDDK00260 TDDK00127 TDDK00325 TDBK00150 TDBK00324 TDBK00340 TDBK00303 TDDK00226 TDBK00158 TDGK00129 TDGK00140 TDDK00117 TDDK00134 TDGK00121 TDDK00333 TDBK00334 TDDK00064 TDDK00102 TDBK00265 TDBK00373 TDDK00172 TDBK00286 TDDK00089 TDDK00277 TDDK00296 TDGK00027 TDGK00088 TDBK00343 TDDK00106 TDDK00213 TDDK00034 TDBK00043 TDGK00069 TDGK00089 TDGK00095 TDBK00368 TDGK00043 TDGK00085 TDGK00093 TDDK00211 TDDK00289 TDDK00063 TDDK00248 TDDK00356 TDBK00346 TDBK00352 TDDK00020 TDDK00092 TDDK00109 TDDK00130 TDDK00186 TDDK00270 TDDK00283 TDDK00275 TDBK00252 TDBK00276 TDDK00187 TDDK00199 TDDK00261 TDGK00113 TDBK00390 TDDK00119 TDBK00305 TDDK00026 TDDK00028 TDDK00051…
FDA’s list runs to 5,535 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 3, 2014.
- FDA classified it on Feb 27, 2015.
- FDA’s Enforcement Report published it on Mar 11, 2015.
- FDA terminated it on Oct 30, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Arjo Hospital Equipment AB, of Malm¿, Sweden.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,535 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.