Medline General Purpose Kit Recalled for Subpotent Povidone-Iodine
Medline Industries is recalling General Purpose 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, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no injuries are explicitly reported, the subpotent nature of a sterile surgical prep product in a Class II recall aligns with the Severe tier for significant risk.
Plain-English summary
Medline Industries, Inc. is recalling 700 cases of Medline General Purpose Kits, Sterile, Single use only. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The specific lots affected are 17GB5136 and 17PB2138, with Pack Number DYNDA1591.
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 product was distributed 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 lots and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Surgical Prep
- Affected units
- 700
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: DYNDA1591
- Lots: 17GB5136
- 17PB2138
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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