Date Initiated by Firm | December 01, 2003 |
Date Posted | December 24, 2003 |
Recall Status1 |
Terminated 3 on April 12, 2004 |
Recall Number | Z-0267-04 |
Recall Event ID |
27824 |
Product Classification |
Stretcher, Wheeled, Powered - Product Code INK
|
Product | Stryker brand Model 1550 Synergy Extended Stay Stretcher |
Code Information |
All stretchers manufactured between 1/1/1993 and 11/07/2003. |
Recalling Firm/ Manufacturer |
Stryker Medical 6300 Sprinkle Rd Kalamazoo MI 49001
|
For Additional Information Contact | Renata Sila 800-669-4968 Ext. 6689 |
Manufacturer Reason for Recall | The user may be pinched by the siderail when raising or lowering the siderail. |
FDA Determined Cause 2 | Other |
Action | Recall letters dated 12/1/03 were sent to each consignee notifying them that Stryker would be contacting them to modify the siderail assembly. |
Quantity in Commerce | 3903 |
Distribution | United States, Canada, Hong Kong, Israel, Mexico and Syria. |
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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