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Class 2 Device Recall HillRom Versacare |
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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
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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
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For Additional Information Contact |
800-445-3720
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Manufacturer Reason for Recall |
The patient pendant cord represents a potential trip hazard for the patient or the caregiver.
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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
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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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