| Date Initiated by Firm | August 29, 2006 |
|---|
| Date Posted | September 22, 2006 |
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| Recall Status1 |
Terminated 3 on April 18, 2007 |
| Recall Number | Z-1513-06 |
|---|
| Recall Event ID |
36149 |
| Product Classification |
Ambulance Cot - Product Code FPO
|
| Product | Stryker Power-PRO Powered Ambulance Cot, Model 6500. |
|---|
| Code Information |
All units with a serial number lower than 060739380. (units manufactured between 1 Oct 2005 and 15 July 2006) |
| FEI Number |
1831750
|
Recalling Firm/
Manufacturer |
Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
|
| For Additional Information Contact | Renata Sila
800-669-4968 Ext. 6689 |
|---|
Manufacturer Reason
for Recall | The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified of the recall via letter dated 8/29/06. Included with the letter were replacement bolts for each cot and installation instructions, but the customer was given the option of contacting the recalling firm for installation. |
|---|
| Quantity in Commerce | 1,841 cots (44 foreign) |
|---|
| Distribution | Worldwide distribution ---- including USA and countries of Canada, China, Germany and Switzerland. |
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| 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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