CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterio
FDA device recall Z-1902-2009 · posted 2009-08-25 · Terminated
Recall details
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Reason for recall
- Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- INX
- Quantity affected
- 625 units (total both units)
- Distribution
- Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
- Date initiated
- 2009-06-24
- Date posted
- 2009-08-25
- Date terminated
- 2012-07-11
- Location
- Charleston, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITRON AIR FLUIDIZED SUPPORT SYSTEM (K813584) | Uhi Corp. | 1982-01-12 |