Medline Povidone-Iodine Prep Pads Recalled for Subpotent Iodine Content
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, and the rubric specifies that FDA Class II recalls with potential for significant health consequences (such as subpotent antiseptic agents) are rated as Severe (4).
Plain-English summary
Medline Industries Inc. is recalling Medline General Purpose Tray, Sterile, Single Use Only, which contains Povidone-Iodine prep pads. The recall was initiated because the titratable iodine contained in the pads is below the label claim of 0.85%.
The affected product is packaged in the USA for Medline Industries, Inc., located in Mundelein, IL. The recall involves 56 cases with Pack Number DYNDL1648 and Lot 17FA0144. 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 affected product and contact Medline Industries for further instructions or a refund. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 56
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: DYNDL1648
- Lots: 17FA0144
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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