| | Class 2 Device Recall HillRom Versacare |  |
| 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. |
| 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 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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