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Class 2 Device Recall Advanta bed |
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Date Initiated by Firm |
March 08, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on September 02, 2004 |
Recall Number |
Z-0726-04 |
Recall Event ID |
28420 |
Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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Product |
Hill Rom brand Advanta bed; model P1600. |
Code Information |
All units distributed between January 1, 2004 and February 11, 2004. |
Recalling Firm/ Manufacturer |
Hill-Rom, Inc. 125 E Pearl St Batesville IN 47006
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For Additional Information Contact |
Technical Support 800-445-3720
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Manufacturer Reason for Recall |
A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed.
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FDA Determined Cause 2 |
Other |
Action |
A recall letter dated March 8, 2004 was sent to each consignee advising them of the problem, and that Hill-Rom will visit the facility to modify the beds. |
Quantity in Commerce |
294 |
Distribution |
California, Delaware, Idaho, Indiana, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, South Dakota, Tennesee and Canada. |
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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