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Terminated

KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas

FDA Recall Z-0414-03 · Posted 2003-01-09

Recalling FirmKinetic Concepts, Inc
Recall StatusTerminated
Product CodeFNL
Date Initiated1998-10-21
Date Terminated2003-01-28
Product Quantity144 Beds (6 of which were out of service prior to correction)

Reason for Recall

Electrical failure of the bed due to fluid egress into the junction box.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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