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Terminated

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

FDA Recall Z-0709-04 · Posted 2004-07-20

Recalling FirmAction Products Incorporated
Recall StatusTerminated
Product CodeKNO
Date Initiated2004-02-02
Date Terminated2004-09-21
Product Quantity389 wheelchairs

Reason for Recall

Wheelchair seat may not properly support the user due to cracks in the plastic seat base.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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