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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 02, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall Number Z-0709-04
Recall Event ID 28201
Product Classification Accessories, Wheelchair - Product Code KNO
Product Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
Code Information Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
Recalling Firm/
Action Products Incorporated
22 N Mulberry St
Hagerstown MD 21740-4910
For Additional Information Contact D. Michelle Laing
301-797-1414 Ext. 1022
Manufacturer Reason
for Recall
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
FDA Determined
Cause 2
Action The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.
Quantity in Commerce 389 wheelchairs
Distribution Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.
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.