Medline Dressing Change Tray Kit Recalled for Subpotent Iodine Content
Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
What this means for you
Illness, injury, or structural failure has been reported. 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 under the rubric, particularly given the subpotent nature of the antiseptic agent.
Plain-English summary
Medline Industries, Inc. is recalling 280 cases of Medline Dressing Change Tray Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The specific Pack Number is DYNDC2282, and the affected Lots are 16CB5897 and 16PB9981.
The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This is classified as a subpotent drug issue.
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. Users should stop using the affected kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 280
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: DYNDC2282
- Lots: 16CB5897
- 16PB9981
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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