3M Recalls DuraPrep Surgical Solution Due to Chemical Contamination
3M is recalling DuraPrep Surgical Solution because the product may be contaminated with a toxic compound.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a toxic chemical contamination, which fits the rubric criteria for high-risk products where injury has not yet been reported.
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…
- Manufacturer
- 3M Company - Health Care Business
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot#: a) 2016-09EE
- 2016-09EF
- 2016-09EG
- Exp 9/30/16
- b) 2016-08DC
- Exp 8/31/16.
Distribution
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