Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0414-03

KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic...

KCI USA, Inc. / initiated 1998-10-21 / Terminated

Kinetic Concepts, Inc began a recall of KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas on . The reason FDA records is "Electrical failure of the bed due to fluid egress into the junction box". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0414-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KCI USA, Inc.
Product
KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
Electrical failure of the bed due to fluid egress into the junction box.
FDA root cause
Other
Action
In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.
Quantity in commerce
144 Beds (6 of which were out of service prior to correction)
Distribution
Nationwide
Product codes and lots
All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.