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U.S. Department of Health and Human Services

Class 2 Device Recall Xact

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  Class 2 Device Recall Xact see related information
Date Initiated by Firm May 14, 2002
Date Posted December 05, 2002
Recall Status1 Terminated 3 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 2		 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.
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