Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat…

Date posted by the FDA

Dec. 5, 2002

Status

Terminated

Filed by

Action Products Incorporated

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.

Reason

Wheelchair seat component is defective.

Distribution pattern

Product was sold to medical supply firms in LA, IN, and MA and to international customers.

Quantity

73 sets

Codes and lots

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

Recall started

May 14, 2002

Device type

Accessories, Wheelchair

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-316/318-3

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-316/318-3. The agency record governs; check it and the company before acting.