Reported Feb 12, 2014 · Terminated
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary…
ArjoHuntleigh Inc.
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: ArjoHuntleigh Inc. · 4958 Stout Dr · San Antonio, TX · 78219-4334
Is this the product you have?
- The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning
- Product UsageUse of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics
- Lot codes and dates
- Model #209500
- Amount recalled
- 231 units
Where it was sold
- Nationwide
Why it was recalled
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
This product could cause temporary or reversible health problems — stop using it.
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