FDA Recall
Terminated
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: Z-1100-04
·
Initiated April 28, 2004
Recall
- Recall Number
- Z-1100-04
- Event Number
- 29263
- Firm
- Steris Corportion
- FEI Number
- 1937531
- Product Code
- JD-01
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 28, 2004
- Posted
- July 20, 2004
- Terminated
- November 15, 2004
- Address
- 7501 Page Ave, Saint Louis, MO, 63133-1031
Description
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.
Reason
The product failed microbial limits specification upon release and was distributed
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.
Distribution
Distribution was made 5 accounts located in IA, FL, NY, AZ, and VA.
Quantity
8/72-bottle cases