Medline Trunk Kit Recalled for Subpotent Povidone-Iodine Concentration
Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
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 rubric, particularly given the subpotent nature of the antiseptic agent.
Plain-English summary
Medline Industries, Inc. is recalling 231 cases of Medline Trunk Kit, Non-sterile. The product is packaged in the USA for Medline Industries, Inc., located in Mundelein, IL. The recall involves specific lots: 17FA0227, 17FA0470, 17FA1431, 17HA0258, and 17HA0259, under Pack Number DYKTRUNK1.
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 antiseptic concentration is lower than what is stated on the product label.
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. Consumers and healthcare providers should stop using the affected lots and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Affected units
- 231
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)
- Pack Number: DYKTRUNK1
- Lots: 17FA0227
- 17FA0470
- 17FA1431
- 17HA0258
- 17HA0259
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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