Medline Debridement Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Debridement Trays because the iodine concentration in the prep pads is below the label claim.
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, which corresponds to a Severe rating (score 4) under the rubric, as Class II recalls involve a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
Medline Industries, Inc. is recalling 90 cases of Medline Debridement Tray, Sterile, Single Use Only. The product was assembled in the USA by Medline Industries, Inc., in Mundelein, IL. The specific pack number for the recalled items is DYNDW1032.
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 agency has classified this recall as Class II.
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 facilities should stop using the recalled trays and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 90
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 (1)
- Pack Number: DYNDW1032
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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