FDA Medical Device Recalls (openFDA)
Kinetic Concepts, Inc: 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
- Recall number
- Z-0129-06
- Recalling firm
- Kinetic Concepts, 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
- Status
- Terminated
- Initiated
- 2004-08-16
- Posted
- 2005-11-08
- Terminated
- 2005-11-08
- Reason
- Design change to uppgrade reliability of powered adjustable bed.
- Root cause
- Other
- Action
- All consignees were notified with a technical bulletin explaining the inspection and addition of washers to the set-screws.
- Quantity
- 93 beds
- Distribution
- Nationwide
- Lot, serial or model codes
- Product Code 80 FNL, BariMaxx II Serial numbers: BKOk00006 through BKOK00100
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 1625774
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28