3M Company - Health Care Business recalls DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperati…

Recall date

August 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1417-2015

FDA classification

Class II

Brand / firm

3M Company - Health Care Business

Sold / distributed

Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.

Why it was recalled

Chemical contamination: Product may be contaminated with a toxic compound.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.