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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Renaissance Series Stretchers

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  Class 2 Device Recall Stryker Renaissance Series Stretchers see related information
Date Initiated by Firm March 19, 2010
Date Posted August 09, 2010
Recall Status1 Terminated 3 on May 02, 2011
Recall Number Z-2185-2010
Recall Event ID 55139
510(K)Number K022309  
Product Classification Powered Wheeled Stretcher - Product Code INK
Product Stryker Renaissance Series Stretchers, Model 1231Z Emergency Care with Zoom, Stryker Medical, Portage, MI.
Code Information Model 1231: 39 Units 0310049178, 0310049179, 0311058120, 0312050809, 0407059532, 0407059533, 0407059656, 0407059657, 0407059851, 0407059852, 0407059853, 0407059854, 0407059855, 0407059856, 0407059857, 0407059858, 0407059859, 0407059860, 0407059861, 0407059862, 0407059863, 0407059864, 0407059865, 0407059866, 0407059867, 0407059868, 0407059869, 0407059870, 0408059073, 0408059123, 0408059124, 0408059871, 0408059872, 0408059873, 0408059874, 0408059875, 0408059876, 0408059877, and 0409062555. 
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
800-787-9537 Ext. 3
Manufacturer Reason
for Recall		 The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
FDA Determined
Cause 2		 Component design/selection
Action The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.
Quantity in Commerce 39 Stretchers
Distribution Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
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.
510(K) Database 510(K)s with Product Code = INK and Original Applicant = STRYKER CORP.
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