Medline Recalls Sterile Povidone-Iodine Prep Pads Due to Low Iodine Content
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.
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 250 cases of Medline All Purpose Instrument Tray, Sterile, which contains Povidone-Iodine prep pads. The product was packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The specific lots affected are 177B0657 and 17QB3332, with Pack Number DYNDL1488.
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 FDA has classified this recall as Class II.
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. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and stop using the affected products if found.
The recalled product
- Product
- Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Antiseptic
- Affected units
- 250
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: DYNDL1488
- Lots: 177B0657
- 17QB3332
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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