Medline Wound Closure Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 80 cases of Wound Closure Trays because the iodine concentration in the prep pads 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, 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 reported, the subpotent nature of a sterile wound care product in a Class II recall warrants a Severe rating under the provided constraints for non-Class I/III significant risks.
Plain-English summary
Medline Industries, Inc. is recalling 80 cases of Medline Wound Closure Trays, sterile, single-use. The product is packaged in Mexico for Medline Industries, Inc., located in Northfield, IL. The affected lots are 17HB4903 and 17CB8548, with Pack Number DYNDA1465.
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 product and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Wound Care
- Affected units
- 80
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: DYNDA1465
- Lots: 17HB4903
- 17CB8548
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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