FDA Medical Device Recalls (openFDA)
Steris Corportion: STERIS Kindest Kare Perineal Cleanser Incontinence System, packaged in 4-fl. oz. bottles (72 per case), Ready-To-Use, No-Rinse Solution, For Pediatric and Geriatric Use, For Hospital and Professional Use Only. The label shows the responsible firm to be STERIS Corporation, St. Louis, MO.
- Recall number
- Z-1100-04
- Recalling firm
- Steris Corportion
- Product
- STERIS Kindest Kare Perineal Cleanser Incontinence System, packaged in 4-fl. oz. bottles (72 per case), Ready-To-Use, No-Rinse Solution, For Pediatric and Geriatric Use, For Hospital and Professional Use Only. The label shows the responsible firm to be STERIS Corporation, St. Louis, MO.
- Status
- Terminated
- Initiated
- 2004-04-28
- Posted
- 2004-07-20
- Terminated
- 2004-11-15
- Reason
- The product failed microbial limits specification upon release and was distributed
- Root cause
- Other
- Action
- The recall was initiated via telephone on 4/28/904 and follow-up letter dated 5/10/04 explaining the reason for recall and requesting return of the product.
- Quantity
- 8/72-bottle cases
- Distribution
- Distribution was made 5 accounts located in IA, FL, NY, AZ, and VA.
- Lot, serial or model codes
- Lot #233026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JD-01
- Firm FEI
- 1937531
- Firm city
- Saint Louis
- Firm state
- MO
- 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