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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 01, 2003
Date Posted June 12, 2003
Recall Status1 Terminated 3 on June 11, 2003
Recall Number Z-0868-03
Recall Event ID 26325
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product Stryker Secure II hospital bed; model 3002.
Code Information serial numbers 030415710, 030415711, 030415712, 030415713, 030415714 and 030415729.
Recalling Firm/
Manufacturer		 Stryker Medical
6300 Sprinkle Rd
Kalamazoo MI 49001
For Additional Information Contact
269-324-6300
Manufacturer Reason
for Recall		 A wire may break at the crimp and present a potential electric shock hazard.
FDA Determined
Cause 2		 Other
Action The firm sent service representatives to the receiving hospitals, beginning on 5/1/02, and the beds were corrected in place.
Quantity in Commerce 6
Distribution Pennsylvania and Kansas
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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