SCRUB BRUSH-SPONGE, SURGICAL

Description of Event or Problem

RED BUMPS ON HEALTHCARE WORKER'S HANDS.

Additional Manufacturer Narrative

SINCE SAMPLES WERE NOT MADE AVAILABLE AND NO LOT NUMBER WAS PROVIDED, A THOROUGH INVESTIGATION COULD NOT BE COMPLETED. FOR EACH RECEIVED LOT OF SOLUTION THAT IS USED TO MANUFACTURE THE SURGICAL SCRUB BRUSH SPONGE, CATALOG NO 4457A, A REVIEW OF THE CERTIFICATE OF ANALYSIS AND AN IDENTIFICATION TEST IS PERFORMED. ADDITIONAL FINISHED GOODS TESTING ARE COMPLETED ON A SKIP LOT BASIS, WHICH INCLUDES A SKIN IRRITATION STUDY, CHEMICAL AND MICROBIOLOGICAL ANALYSIS. REVIEW OF THESE TEST RECORDS DOES NOT INDICATE FAILURE OF PREVIOUS LOTS. CAREFUSION WILL CONTINUE TO MONITOR AND TREND THIS ISSUE AND UTILIZE THE INFORMATION AS PART OF OUR CONTINUOUS IMPROVEMENT PROGRAM.