Reported Mar 11, 2015 · Terminated
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a…
Arjo Hospital Equipment AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arjo Hospital Equipment AB · HANS MICHELSENSGATAN 10 · Malm¿, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- SERIAL NUMBERS
552 of 552 codes
TDBK00046TDBK00096TDDK00006TDDK00008TDDK00122TDDK00126TDDK00254TDBK00281TDDK00265TDBK00292TDBK00134TDDK00036TDDK00149TDDK00363TDBK00323TDBK00355TDBK00370TDDK00035TDDK00066TDBK00348TDBK00360TDDK00184TDDK00242TDGK00116TDGK00117TDGK00123TDBK00049TDGK00024TDDK00118TDBK00349TDDK00021TDDK00245TDBK00033TDBK00250TDBK00320TDDK00054TDDK00158TDDK00224TDGK00026TDGK00032TDBK00070TDDK00062TDDK00231TDDK00278TDBK00131TDBK00284TDBK00319TDBK00367TDDK00121TDDK00255TDDK00285TDBK00058TDBK00280TDDK00202TDDK00217TDDK00005TDDK00155TDDK00183TDDK00252TDDK00269
- SERIAL NUMBERS
- Amount recalled
- 567 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The recalled devices labeling and instructions for use contain unapproved medical claims.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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