Medline Sheath Removal Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration 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, but the hazard is a subpotent drug (lower than labeled concentration) rather than a toxic contamination or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries, Inc. is recalling 40 cases of Medline Sheath Removal Kits, sterile, single use only. The product was packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. 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 product is identified by Pack Number DYNDA1356 and Lot 17DB2820. Distribution was nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
Consumers and healthcare facilities should stop using the recalled product and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic Prep Pads
- Affected units
- 40
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: DYNDA1356
- Lots: 17DB2820
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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