3M Recalls DuraPrep Surgical Solution Due to Chemical Contamination

Plain-English summary

3M Company - Health Care Business is recalling DuraPrep Surgical Solution Iodine Povacrylex and Isopropyl Alcohol Patient Preoperative Skin Preparation. The recall involves specific lots of the product, including 0.9 fl oz and 0.2 fl oz single-use applicators, which were distributed nationwide, to Puerto Rico, and to foreign distribution centers in the Dominican Republic, Malaysia, Mexico, Panama, Peru, and the United Arab Emirates.

The recall was initiated because the product may be contaminated with a toxic compound. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and consumers who have the affected lots should stop using the product and contact 3M for further instructions or a refund. The affected lot numbers are 2016-09EE, 2016-09EF, 2016-09EG, and 2016-08DC.

The recalled product

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 pe

Manufacturer

3M Company - Health Care Business

Category

Medical Device — Surgical Preparation

Hazard

• chemical-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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