Medline Concordia Nurse Bag Kit Recalled for Subpotent Iodine Concentration
Medline Industries is recalling 51 cases of Concordia Nurse Bag 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving subpotent drugs where the lack of expected efficacy poses a significant risk.
Plain-English summary
Medline Industries, Inc. is recalling 51 cases of the Medline Concordia Nurse Bag Kit. The product is packaged in the USA for Medline Industries, Inc., located in Northfield, IL. The specific items affected are identified by Pack Number DYKM1425 and Lot 17BA1030.
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, meaning the active ingredient is present in a lower concentration than stated on the packaging.
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 affected Povidone-Iodine prep pads and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Topical Antiseptic
- Affected units
- 51
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: DYKM1425
- Lots: 17BA1030
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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