H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International

[UPDATED 10/03/2011] Additional Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers.

[UPDATED 05/03/2011] Consumers using one of the affected First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.

[Posted 03/18/2011]

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

BACKGROUND: Povidone Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.

RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Download form2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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