Medline Recalls Pediatric IV Kits With Subpotent Iodine Concentration
Medline Industries is recalling Pediatric IV 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, which corresponds to a Severe severity score per the rubric.
Plain-English summary
Medline Industries, Inc. is recalling 50 cases of Medline Pediatric IV Kits. The recall is due to the titratable iodine contained in the Povidone-Iodine prep pads being below the label claim of 0.85%.
The affected product is identified by Pack Number DYKP1000A and Lot 17AA2252. The kits 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 kits and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — IV Kits
- Hazard
- Affected units
- 50
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: DYKP1000A
- Lots: 17AA2252
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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