| | Class 2 Device Recall Stryker MSeries Stretcher |  |
| Date Initiated by Firm | March 19, 2010 |
|---|
| Date Posted | August 09, 2010 |
|---|
| Recall Status1 |
Terminated 3 on May 02, 2011 |
| Recall Number | Z-2184-2010 |
|---|
| Recall Event ID |
55139 |
| 510(K)Number | K022309 |
|---|
| Product Classification |
Powered Wheeled Stretcher - Product Code INK
|
| Product | Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI. |
|---|
| Code Information |
Model 1025: 4,558 Units 0407059118, 0409062887, 0409062888, 0411061803, 0411061805, 0411065113, 0411065220, 0411065270, 0411065271, 0411065272, 0411065273, 0411065370, 0412062084, 0412062085, 0412062086, 0412062087, 0412062090, 0412062109, 0412062110, 0412062136, 0412062137, 0412062148, 0412062149, 0412062150, 0412062186, 0412062313, 0412062314, 0412062315, 0412062344, 0412062345, 0412062346, 0412062359, 0412062360, 0412062411, 0412062412, 0412062426, 0412062428, 0412062429, 0412062430, 0412062453, 0412062454, 0412062457, 0412062458, 0412062459, 0412062493, 0412062494, 0412062498, 0412062499, 0412062500, 0412063501, 0412063502, 0412063671, 0412063672, 0412063673, 0412063674, 0412063724, 0412063725, 0412063726, 0412063727, 0412063951, 0412063952, 0412063955, 0412063982, 0412063994, 0412063995, 0412063996, 0412063997, 0501071636, 0501071638, 0501071779, 0501071859, 0501071860, 0501071956, 0501071957, 0501071958, 0501071959, 0501071960, 0501072488, 0501072489, 0501072490, 0502070650, 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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 | 4,558 Stretchers |
|---|
| Distribution | Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East. |
|---|
| 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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| 510(K) Database | 510(K)s with Product Code = INK
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