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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.

FDA Recall Z-1100-04 · Posted 2004-07-20

Recalling FirmSteris Corportion
Recall StatusTerminated
Product CodeJD-01
Date Initiated2004-04-28
Date Terminated2004-11-15
Product Quantity8/72-bottle cases

Reason for Recall

The product failed microbial limits specification upon release and was distributed

Firm 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.

Root Cause

Other

Distribution Pattern

Distribution was made 5 accounts located in IA, FL, NY, AZ, and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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