CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
- Company
- Hill-Rom Manufacturing, Inc.
- Recall Initiated
- June 24, 2009
- Posted
- August 25, 2009
- Terminated
- July 11, 2012
- Recall Number
- Z-1902-2009
- Quantity
- 625 units (total both units)
- Firm Location
- Charleston, SC
Reason for Recall
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Distribution
Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
Lot / Code Info
All serial numbers.
Root Cause
Equipment maintenance
Action Taken
Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
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