Medline Vaginal Delivery CDS Pack Recalled for Subpotent Iodine
Medline Industries is recalling Vaginal Delivery CDS Packs because the iodine content is below the label claim.
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 severity score per the rubric.
Plain-English summary
Medline Industries, Inc. is recalling 2 cases of Medline Vaginal Delivery CDS Packs, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL.
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%. The affected product has Pack Number CDS830006I and Lot 17IB3974.
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 providers should stop using the affected product and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Hazard
- Affected units
- 2
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: CDS830006I
- Lots: 17IB3974
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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