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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 29, 2004
Date PostedDecember 22, 2004
Recall Status1 Terminated 3 on June 02, 2005
Recall NumberZ-0346-05
Recall Event ID 30529
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductHill-Rom CareAssist Bed; model P1170.
Code Information All units shipped prior to September 22, 2004.
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		Warning label containing instructions for proper electrical grounding was not attached.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter dated 11/29/04 and provided labels to affix to their beds.
Quantity in Commerce1,825
DistributionNationwide, Canada and Saudi Arabia.
Total Product Life CycleTPLC Device Report
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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