Medline Suture Removal Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim of 0.85%.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving significant injury or structural defects, though here it is a subpotent drug issue which still warrants a high severity due to the potential for treatment failure.
Plain-English summary
Medline Industries, Inc. is recalling 1,250 cases of Medline Suture Removal Kits, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Mundelein, IL. The specific product code is Pack Number DYNDS1010, Lots 15EB9408.
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. Consumers and healthcare providers should stop using the affected lots and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Affected units
- 1,250
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 (2)
- Pack Number: DYNDS1010
- Lots 15EB9408
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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