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U.S. Department of Health and Human Services

Class 2 Device Recall Eagle Parts and Products

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  Class 2 Device Recall Eagle Parts and Products see related information
Date Initiated by Firm July 11, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 on September 05, 2012
Recall Number Z-0040-2007
Recall Event ID 36213
510(K)Number K990122  
Product Classification Power Wheel Chairs - Product Code ITI
Product Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Code Information Serial numbers 624EZ0010 through 624EZ0513.
Recalling Firm/
Manufacturer		 Eagle Parts and Products
1411 Marvin Griffin Rd
Augusta GA 30906-3852
Manufacturer Reason
for Recall		 The wheel hub bolts may loosen resulting in the wheels coming off.
FDA Determined
Cause 2		 Other
Action Consignees were first notified by letter on 07/11/2006. Recall was expanded to include all units on 07/28/2006.
Quantity in Commerce 365 units (total for both models)
Distribution AL, FL, GA, KY, NC, SC TN, TX
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.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = EAGLE PARTS & PRODUCTS, INC.
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