Class 2 Device Recall Stryker stretcher

• Date Initiated by Firm: May 07, 2007
• Date Posted: September 21, 2007
• Recall Status: Terminated on June 11, 2008
• Recall Number: Z-1009-2007
• Recall Event ID: 37978
• Product Classification: Stretcher - Product Code FPO
• Product: Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales)
• Code Information: Serial numbers 0508083666, 0509069531, 0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564, 0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588, 0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664, 0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697, 0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771, 0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777, 0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817, 0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837, 0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849, 0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024, 0510071025, 0510071026, 0510071032, 0510071033, 0510071034, 0510071035, 0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041, 0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157, 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• Recalling Firm/ Manufacturer: Stryker Medical Div. of Stryker Corporation; 3800 E. Centre Ave.; Portage MI 49002
• For Additional Information Contact: Mike Mazelin; 800-669-4968 Ext. 6687
• Manufacturer Reason for Recall: The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.
• FDA Determined Cause: Other
• Action: Consignees were notified of the problem via letter dated 5/7/07 instructing them to immediately unplug the affected stretchers with scales, affix a warning label enclosed with the letter to the power cord of stretchers with scales, and that they will be contacted so that the firm can schedule a visit to upgrade all affected stretchers. A second notification letter was issued on August 7, 2007 to cover all 1550 stretchers with and without scales.
• Quantity in Commerce: 1,048 (1009 in the U.S. plus 39 international)
• Distribution: Worldwide: USA, Latin America, Mexico and Spain.
• 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.