Medline IV Circulation Pack Recalled for Subpotent Iodine Prep Pads
Medline is recalling IV Circulation Packs because the iodine prep pads contain less iodine than labeled. The product was distributed in the US and 10 other countries.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a subpotent antiseptic rather than a high-risk pathogen or structural defect.
Plain-English summary
Medline Industries Inc is recalling 51 cases of Medline CC Drawer 4 IV Circulation Packs. The recall is due to the titratable iodine in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected product is identified by Pack Number ACC010254A and Lots 17HD4376 and 17HD1709. The product was distributed nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Healthcare providers and consumers should stop using the affected IV Circulation Packs and contact Medline Industries Inc for further instructions or a return.
The recalled product
- Product
- Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Affected units
- 51
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 (3)
- Pack Number: ACC010254A
- Lots: 17HD4376
- 17HD1709
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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