Medline Recalls Subpotent Povidone-Iodine Catheter Insertion Trays
Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.
What this means for you
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a subpotent antiseptic, which is a lower risk than a potent contaminant or structural defect, fitting the Moderate category for low-risk contamination or labeling discrepancies.
Plain-English summary
Medline Industries, Inc. is recalling Liberator Medical Supply Catheter Insertion Trays, Sterile, Single Use Only. The recall involves 20,430 cases of the product, which was distributed nationwide in the USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The specific product is identified by Pack Number DYNDT1022E and Lots 17QB4402 and 17TB1979.
The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This subpotent condition means the product may not provide the intended antiseptic effect as described on the packaging.
Healthcare facilities and distributors should stop using the affected product and contact Medline Industries for further instructions. Consumers who have purchased this product should contact their healthcare provider or the manufacturer for guidance on disposal or replacement.
The recalled product
- Product
- Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 20,430
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: DYNDT1022E
- Lots 17QB4402
- 17TB1979
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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