Z-0129-06

Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O...

Name: Z-0129-06 Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O...
Creator: Kinetic Concepts, Inc
Published: 2004-08-16
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2004-08-16 / Terminated / root cause: design

FDA source

Kinetic Concepts, Inc began a recall of Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call... on 2004-08-16. The reason FDA records is "Design change to uppgrade reliability of powered adjustable bed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0129-06
Status: Terminated
Initiated: 2004-08-16
Posted: 2005-11-08
Terminated: 2005-11-08
Recalling firm: KCI USA, Inc.
Product: Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com
Product code: FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall: Design change to uppgrade reliability of powered adjustable bed.
Root cause tag: design
FDA root cause: Other
Action: All consignees were notified with a technical bulletin explaining the inspection and addition of washers to the set-screws.
Quantity in commerce: 93 beds
Distribution: Nationwide
Product codes and lots: Product Code 80 FNL, BariMaxx II Serial numbers: BKOk00006 through BKOK00100

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)