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U.S. Department of Health and Human Services

Class 2 Device Recall Resident LT bed ambulatory assist bar

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 Class 2 Device Recall Resident LT bed ambulatory assist barsee related information
Date Initiated by FirmNovember 14, 2003
Date PostedDecember 10, 2003
Recall Status1 Terminated 3 on August 06, 2004
Recall NumberZ-0206-04
Recall Event ID 27711
Product Classification unknown device name - Product Code KMM
ProductHill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.
Code Information All units distributed between March 1997 and September 2003.
FEI Number 1824206
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
ActionCustomers 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 Commerce1400
DistributionUnited 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.
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