Reported Sep 16, 2015 · Terminated
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient…
3M Company - Health Care Business
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 3M Company - Health Care Business · 3M Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN · 55144
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 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 |
| 2 | and |
| 3 | 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. |
- Lot codes and dates
Lot#: a) 2016-09EE2016-09EF2016-09EGExp 9/30/16b) 2016-08DCExp 8/31/16
- Amount recalled
- 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)
Where it was sold
- Nationwide
- PR
Why it was recalled
Chemical contamination: Product may be contaminated with a toxic compound.
This product could cause temporary or reversible health problems — stop using it.
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