Medline Incision Drainage Kit Recalled for Subpotent Iodine Content
Medline is recalling Incision Drainage Kits because the iodine content is below the labeled claim. The product was distributed nationwide and internationally.
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, but the source text does not report any illnesses or injuries, and the hazard is a subpotent antiseptic rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Medline Industries Inc is recalling 149 cases of Medline Incision Drainage Kits, Sterile, Single Use Only. The recall is due to the titratable iodine contained in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected products are identified by Pack Number P888943 and P888943H, with Lot 17RB8662. The products were packaged in Mexico by Medline Industries, Inc., in Mundelein, IL. Distribution included the United States, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare facilities should stop using the affected products and contact Medline Industries Inc for further instructions or a refund.
The recalled product
- Product
- Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 149
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: P888943
- Lots 17RB8662 Pack Number: P888943H
- Lots 17RB8662
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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