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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom Versacare

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  Class 2 Device Recall HillRom Versacare see related information
Date Initiated by Firm July 27, 2006
Date Posted October 05, 2006
Recall Status1 Terminated 3 on April 10, 2008
Recall Number Z-0017-2007
Recall Event ID 36143
Product Classification hospital bed - Product Code FNL
Product Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Code Information All model P3200 VersaCare beds with the optional patient pendants P3207A01 or P3207A02.
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 patient pendant cord represents a potential trip hazard for the patient or the caregiver.
FDA Determined
Cause 2
Other
Action Consignees were notified via a letter dated 8/10/06 that included a package with installation instructions, materials and labels to modify the beds.
Quantity in Commerce 36,645
Distribution Nationwide, Argentina, Australia, Brazil, Canada, China, Greece, Indonesia, Japan, Kuwait, Oman, Qatar, Thailand and United Arab Emirates.
Total Product Life Cycle TPLC 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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