Medline Recalls IV Start Kits With Subpotent Povidone-Iodine
Medline Industries is recalling IV Start Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
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 injuries are explicitly reported, the subpotent nature of a sterile medical device used for skin prep in invasive procedures carries a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the defect is significant.
Plain-English summary
Medline Industries, Inc. is recalling Medline IV Start Kits, sterile, single-use devices packaged in Mexico. The recall involves 10,375 cases distributed nationwide in the United States, as well as in Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
The recall was initiated because the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%. This condition is classified as a subpotent drug issue. The affected products are identified by Pack Number DYND74077 with Lots 16GB2754, 17GB3103, 16IB7722, and 17EB6063, and Pack Number DYND74077H with Lots 17EB6063 and 17GB3103.
Healthcare providers and facilities should check their inventory for these specific lot and pack numbers. If the affected products are found, they should be removed from use and returned to Medline Industries, Inc. according to the company's instructions.
The recalled product
- Product
- Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — IV Start Kits
- Affected units
- 10,375
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 (6)
- Pack Number: DYND74077
- Lots: 16GB2754
- 17GB3103
- 16IB7722
- 17EB6063 Pack Number: DYND74077H
- Lots: 17EB6063
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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