RecallDepth
Class II Terminated

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.

This recall has been terminated (originally issued September 16, 2015).

Company
3M Company - Health Care Business
Recall Initiated
August 6, 2015
Posted
September 16, 2015
Recall Number
D-1417-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
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)
Firm Location
Saint Paul, MN, United States
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

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

Lot / Code Info

Lot#: a) 2016-09EE, 2016-09EF, 2016-09EG, Exp 9/30/16; b) 2016-08DC, Exp 8/31/16.

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