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Tag Archives: PDI
RECALL OF PDI NON-STERILE ALCOHOL WIPES RAISES ADDITIONAL QUESTIONS SAYS MSNBC.COM
FRIEDMAN QUOTED AS SAYING THAT NON-STERILE GAUZE PADS SHOULD NOT BE USED WITH INJECTABLES COMMENT JoNel Aleccia, Health Writer for MSNBC.com, questions the use of non-sterile wipes based upon a massive recall of potentially contaminated alcohol prep products by a second manufacturer. … Continue reading
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC, ORANGEBURG, NY RECEIVES FORM FDA 483 (7/5/11)
BACILLUS CEREUS RECOVERED FROM APPLICATOR USED TO MANUFACTURE NON-STERILE ALCOHOL PREP PADS OBSERVATION 1 Each lot of a component that is liable for microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests … Continue reading
PDI, ORANGEBURG, NY IS RECALLING 285 MILLION NON-STERILE ALCOHOL PADS AS PER FDA ENFORCEMENT REPORT (10/5/11)
NON-STERILE WIPES FOUND TO BE CONTAMINATED BY FDA SAMPLING AND ANALYSES COMMENT FDA sampling and analyses of non-sterile alcohol prep pads were found to be contaminated with Bacillus cereus. Based on USP<61> and <62> wherein “specified” in-house microorganisms are considered … Continue reading
SECOND WIPE-MAKER ISSUES RECALL AFTER BACTERIA DETECTED
NON-STERILE WIPES RECALLED ON SEPTEMBER 16, 2011 FOLLOWING DISCOVERY OF LOW LEVELS OF BACILLUS CEREUS COMMENT Bacillus cereus was recently identified within non-sterile alcohol prep wipes manufactured by Professional Disposables International Inc (PDI), Orangeburg, NY. The recall of five lots … Continue reading
Barry A Friedman, PhD LLC 