Date Initiated by Firm |
November 29, 2004 |
Date Posted |
December 22, 2004 |
Recall Status1 |
Terminated 3 on June 02, 2005 |
Recall Number |
Z-0346-05 |
Recall Event ID |
30529 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
|
Product |
Hill-Rom CareAssist Bed; model P1170. |
Code Information |
All units shipped prior to September 22, 2004. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
|
For Additional Information Contact |
800-445-3720
|
Manufacturer Reason for Recall |
Warning label containing instructions for proper electrical grounding was not attached.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter dated 11/29/04 and provided labels to affix to their beds. |
Quantity in Commerce |
1,825 |
Distribution |
Nationwide, Canada and Saudi Arabia. |
Total Product Life Cycle |
TPLC Device Report
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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.
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