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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 1050 hospital stretcher

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  Class 2 Device Recall Stryker 1050 hospital stretcher see related information
Date Initiated by Firm December 30, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 15, 2004
Recall Number Z-0304-04
Recall Event ID 27990
Product Classification Stretcher, Wheeled, Powered - Product Code INK
Product Stryker brand Synergy extended stay stretcher; model 1050
Code Information All units.
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		 Users may be pinched in the siderail assembly when raising or lowering the siderail.
FDA Determined
Cause 2		 Other
Action Customers were sent a recall letter dated December 30, 2003. The firm will visit each facility and modify the siderail assembly.
Quantity in Commerce 107
Distribution United States and Colombia.
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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