Exact FDA event identifier

Event 71837

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 06, 2015
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: 3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-1417-2015

Recall number: D-1417-2015
Initiated: August 06, 2015
Classification: Class II
Status: Terminated
Recalling firm: 3M Company - Health Care Business
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)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Chemical contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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