FDA Medical Device Recalls (openFDA)
ArjoHuntleigh: ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions.
- Recall number
- Z-1946-2009
- Recalling firm
- ArjoHuntleigh
- Product
- ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions.
- Status
- Terminated
- Initiated
- 2009-06-11
- Posted
- 2009-09-08
- Terminated
- 2010-08-19
- Reason
- Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
- Root cause
- Device Design
- Action
- ArjoHuntleigh sent Urgent Device Field Correction letters dated June 11, 2009, along with the Urgent Field Safety Notice ID 090526AHE dated May 26, 2009, via UPS Ground delivery. Customers were informed of the affected device and were requested to complete the response form with new contact information and fax it back to ArjoHuntleigh at 630-567-5012 or 630-925-7969. For further questions, contact ArjoHuntleigh at 1-800-323-1245.
- Quantity
- 1,987 hygiene chairs
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Model Number: BIB2003-01, all Serial Numbers below 0905000031.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSA
- Firm FEI
- 3007515958
- Firm city
- Addison
- Firm state
- IL
- 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