| 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. |
| FEI Number |
1831750
|
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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