Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0709-04

Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base...

Action Products, Inc. / initiated 2004-02-02 / Terminated

Action Products Incorporated began a recall of Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions on . The reason FDA records is "Wheelchair seat may not properly support the user due to cracks in the plastic seat base". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0709-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Action Products, Inc.
Product
Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
Product code
KNO Accessories, Wheelchair
Reason for recall
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
FDA root cause
Other
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.
Product codes and lots
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.