Class 2 Device Recall EZPro

• Date Initiated by Firm: August 17, 2004
• Date Posted: October 20, 2004
• Recall Status: Terminated on October 19, 2004
• Recall Number: Z-0023-05
• Recall Event ID: 29864
• Product Classification: Stretcher, Wheeled - Product Code FPO
• Product: Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
• Code Information: Serial numbers 040639739, 040639849, 040639737, 040639738, 040639675, 040639674, 040639670, 040639671, 040639672, 040639716, 040639847, 040639848, 040639935, 040639936 and 040639937.
• Recalling Firm/ Manufacturer: Stryker Medical; 6300 Sprinkle Rd; Kalamazoo MI 49001
• For Additional Information Contact: Renata Sila; 269-324-6689
• Manufacturer Reason for Recall: Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.
• FDA Determined Cause: Other
• Action: Service representatives visited each customer, inspected the cots, and reinstalled the lock pins, if required, beginning on August 10, 2004.
• Quantity in Commerce: 15
• Distribution: Alabama, California, Florida, Kansas, Montana, Oklahoma, Texas and Virginia.
• 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.