Medline CNTRL Line Removal Kit Recalled for Subpotent Iodine Content
Medline Industries is recalling CNTRL Line Removal Kit Scripps because the iodine content 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, and the rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported in the text, the subpotent nature of a medical prep product in a Class II recall aligns with the Severe tier criteria for significant potential harm or agency classification weight.
Plain-English summary
Medline Industries, Inc. is recalling 375 cases of the Medline CNTRL Line Removal Kit Scripps. The product is packaged in the USA for Medline Industries, Inc., located in Northfield, IL. The specific pack number is DYKSCRIPPSCL1 and the lot number is 17HA1756.
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 facilities should stop using the affected product and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Medical Prep
- Affected units
- 375
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: DYKSCRIPPSCL1
- Lots: 17HA1756
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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