Medline RAD NECK ENT TRAY Povidone-Iodine Prep Pads Recalled for Subpotency
Medline Industries is recalling RAD NECK ENT TRAY packs because the Povidone-Iodine prep pads contain subpotent iodine levels 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant product defects like subpotency in medical devices.
Plain-English summary
Medline Industries, Inc. is recalling 4 cases of Medline RAD NECK ENT TRAY Packs, Single Use Only. The product is packaged in the USA for Medline Industries, Inc., located in Northfield, IL. The specific pack number is DYKA1220 and the lot number is 17FA1301.
The recall is due to a subpotent drug issue. The titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This means the active ingredient is present at a lower concentration than stated on the packaging.
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 further instructions or a refund.
The recalled product
- Product
- Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 4
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: DYKA1220
- Lots: 17FA1301
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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