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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 1550 Synergy Extended Stay Stretcher

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  Class 2 Device Recall Stryker 1550 Synergy Extended Stay Stretcher see related information
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

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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