Medline Suture Removal Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled 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. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly given the subpotent nature of the antiseptic agent which may compromise infection control.
Plain-English summary
Medline Industries, Inc. is recalling 100 cases of Medline Suture Removal Kits, Sterile, Single Use Only. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The specific lots affected are 16XB4041, 175B2487, and 17PB8309, with Pack Number DYNDR1199.
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 providers should stop using the affected lots and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Affected units
- 100
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 (4)
- Pack Number: DYNDR1199
- Lots 16XB4041
- 175B2487
- 17PB8309
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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