Medline Recalls Povidone-Iodine Prep Pads Due to Subpotent Iodine Levels
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.
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 in a sterile medical context.
Plain-English summary
Medline Industries, Inc. is recalling 3,300 cases of Medline General Purpose Instrument Set, Sterile, Single Use Only. The specific issue involves the Povidone-Iodine prep pads contained in these sets, where the titratable iodine content is below the label claim of 0.85%.
The affected products were packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The recall includes items with Pack Number DYNDS1014 and Lots 17GB3416 and 176B2045.
Distribution was 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 prep pads and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 3,300
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: DYNDS1014
- Lots 17GB3416
- 176B2045
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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