Date Initiated by Firm |
November 14, 2003 |
Date Posted |
December 10, 2003 |
Recall Status1 |
Terminated 3 on August 06, 2004 |
Recall Number |
Z-0206-04 |
Recall Event ID |
27711 |
Product Classification |
unknown device name - Product Code KMM
|
Product |
Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A. |
Code Information |
All units distributed between March 1997 and September 2003. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
|
For Additional Information Contact |
800-445-3720
|
Manufacturer Reason for Recall |
The ambulatory assist bar may not lock into position and may come out of place due to incorrect assembly.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were advised of the recall by letter dated 11/12/03 and mailed on 11/14/03. A Hill-Rom representative will visit each customer to assure the latching mechanism is properly attached to the bed. |
Quantity in Commerce |
1400 |
Distribution |
United States and Canada |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|