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U.S. Department of Health and Human Services

Class 3 Device Recall STERIS Kindest Kare Perineal Cleanser

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 Class 3 Device Recall STERIS Kindest Kare Perineal Cleansersee related information
Date Initiated by FirmApril 28, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 15, 2004
Recall NumberZ-1100-04
Recall Event ID 29263
Product Classification unknown device name - Product Code JD-01
ProductSTERIS 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.
Code Information Lot #233026
FEI Number 1937531
Recalling Firm/
Manufacturer		 Steris Corportion
7501 Page Ave
Saint Louis MO 63133-1031
For Additional Information ContactMs. Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall		The product failed microbial limits specification upon release and was distributed
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce8/72-bottle cases
DistributionDistribution was made 5 accounts located in IA, FL, NY, AZ, and VA.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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