CLINITRON CII Air Fluidized Therapy unit.
FDA device recall Z-0989-03 · posted 2003-07-10 · Terminated
Recall details
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Reason for recall
- Malfunction of side-rail latching pin coupled with inadequate directions for use.
- Action taken
- Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- INX
- Quantity affected
- 122 units (including both units)
- Distribution
- The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the
- Date initiated
- 2003-05-05
- Date posted
- 2003-07-10
- Date terminated
- 2004-07-26
- 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 |