3M Company - Health Care Business recalls DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperativ
Recalled September 16, 2015 · FDA recall D-1417-2015 · 3M Company - Health Care Business
Hazard
Chemical contamination: Product may be contaminated with a toxic compound. · FDA Class II
Units
a) 4460 cases (0.9 fl oz, 26 mL Single Use Applicator, 20 pouches per case), b) 1059 cases (2 fl oz, 6 mL Single Use Applicator, 50 pouches per case)
Sold at
Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.
Description
Chemical contamination: Product may be contaminated with a toxic compound.
Product
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144.
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →