Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download INFORMATIONAL ALERT August 29, 2011
Document related concepts
no text concepts found
Transcript
INFORMATIONAL ALERT August 29, 2011 TO: Eye Banks, Executive Directors and Medical Directors FROM: Jennifer DeMatteo, EBAA Director of Regulations and Standards SUBJECT: Recall of H&P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions and Prep Gel All lots (beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel manufactured by H & P Industries (Hartland, Wisconsin) have been recalled at the request of the FDA. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. These products were distributed nationwide to healthcare consumers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles. See the list below for the various distributors of the affected Povidone Iodine products. You should not use the affected products and should return it to the place it was purchased for a full refund. Consumers with questions can call H&P Industries, Inc. at 262-538-2907 Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time. Report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. The link to the MedWatch Safety Alert is below: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm 269800.htm Swabsticks Amerinet Cardinal Health Nova Plus PSS Select - Select Medical Products Triad Triad Plus Prep Solutions American Fare - Smart Sense, Kmart Amerinet Equaline, Albertson's Fred's Good Neighbor - Good Neighbor Pharmacy, Amerisource Bergen Good Sense - Geiss, Destin & Dunn, Inc. Leader - Cardinal Health Major Meijer Nova Plus Premiere Value - Chain Drug Consortium PSS Select - Select Medical Products. PSS World Medical Triad - Triadine Triad Plus Walgreens Winn Dixie - Medic Gel Triad Plus Scrub Amerinet Nova Plus Triad Triad Plus
