FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboa
FDA device recall Z-0058-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Reason for recall
- Reports of patient entrapment between mattress and side-rails.
- Action taken
- Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tips For Reducing the Risk of Patient Entrapment.
- Root cause
- Other
- Status
- Terminated
- Product code
- IOQ
- Quantity affected
- 515 units
- Distribution
- Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.
- Date initiated
- 2003-08-27
- Date posted
- 2003-10-24
- Date terminated
- 2004-07-01
- 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 |
|---|---|---|
| FLEXICAIR (K863047) | Ssi Medical Services, Inc. | 1986-09-05 |