Medline Recalls Subpotent Povidone-Iodine Prep Pads
Medline Industries is recalling Povidone-Iodine prep pads because the iodine content is below the labeled 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) in the rubric, particularly given the potential for reduced antiseptic efficacy in a sterile medical context.
Plain-English summary
Medline Industries Inc. is recalling Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The recall involves 2,336 cases of the product.
The recall is due to a subpotent drug issue. The titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This means the product may not provide the expected level of antiseptic efficacy.
The affected products were distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific pack numbers involved are DYNDT1094 and DYNDT1094H. Consumers and healthcare providers should check their inventory for these pack numbers and stop using the affected products.
The recalled product
- Product
- Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Prep
- Affected units
- 2,336
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 (1)
- Pack Number: DYNDT1094 and DYNDT1094H
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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