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U.S. Department of Health and Human Services

Class 2 Device Recall EZPro

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  Class 2 Device Recall EZPro see related information
Date Initiated by Firm August 17, 2004
Date Posted October 20, 2004
Recall Status1 Terminated 3 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 2
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.
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