Recall record at a glance
| Official record | D-1417-2015 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | 3M Company - Health Care Business |
| Report date | Sep 16, 2015 |
| Recall initiation date | Aug 6, 2015 |
| 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) |
| Location | Saint Paul, MN, United States |
Official product description
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.
Why the product was recalled
Chemical contamination: Product may be contaminated with a toxic compound.
Distribution information
Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.