Class 2 Device Recall Xact

• Date Initiated by Firm: May 14, 2002
• Date Posted: December 05, 2002
• Recall Status: Terminated on December 10, 2002
• Recall Number: Z-316/318-3
• Recall Event ID: 25070
• Product Classification: Accessories, Wheelchair - Product Code KNO
• Product: Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.
• Code Information: Drop Hooks are components of the wheelchair seat cushions coded as XLPD1516 XLPD1616 XLPD1618 XLPD1816 XLPD1717 XLPD1818 XLPI1516 XLPI1616 XLPI1816 XLPI1717 XLPI1818 XD... followed by one or more of the following, listed in product number: IDS, 05D, 1D, and 15D
• Recalling Firm/ Manufacturer: Action Products Incorporated; 22 N Mulberry Street; Hagerstown MD 21740
• For Additional Information Contact: D. Michelle Laing; 301-797-1414
• Manufacturer Reason for Recall: Wheelchair seat component is defective.
• FDA Determined Cause: Other
• Action: Firm notified customers by certified letter 5/14/02 and advised of potential for serious injury. Letter instructs customers to cease use and distribution of any defective hooks and return for replacement. Firm additonally instructed dealers to notify end-users about the recall.
• Quantity in Commerce: 73 sets
• Distribution: Product was sold to medical supply firms in LA, IN, and MA and to international customers.
• 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.