Medline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the label claim of 0.85%.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating (Score 4) under the provided rubric.
Plain-English summary
Medline Industries, Inc. is recalling 80 cases of Medline General Purpose Tray, Sterile, Single Use Only, which contain Povidone-Iodine prep pads. The recall is due to the titratable iodine content being below the label claim of 0.85%.
The affected product is identified by Pack Number DYNDR1071 and Lot 17FA1640. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare facilities should stop using the affected product and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 80
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 (2)
- Pack Number: DYNDR1071
- Lots: 17FA1640
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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