Medline Anesthesia Kit Recalled for Subpotent Povidone-Iodine Concentration
Medline Industries is recalling 60 cases of Anesthesia Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
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 FDA classified this recall as Class II, which corresponds to a Severe severity score under the rubric for agency classifications.
Plain-English summary
Medline Industries, Inc. is recalling 60 cases of Medline Anesthesia Kits, Single Use Only. The recall is due to a subpotent drug issue where the titratable iodine in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected products were packaged in Mexico by Medline Industries, Inc., located in Northfield, IL. The specific pack number is DYNJAA6606, and the lots involved are 178B1823 and 17HB2055.
Distribution of the recalled product was nationwide in the USA, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey. The FDA has classified this recall as Class II.
The recalled product
- Product
- Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 60
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: DYNJAA6606
- Lots 178B1823
- 17HB2055
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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