Centurion Neonatal IV Access Set Recalled for Iodine Assay Failure
Centurion Medical Products is recalling Neonatal IV Access Sets because the PVP Prep Pad does not meet required iodine levels for shelf life.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling/shelf-life discrepancy (iodine assay level) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Centurion Medical Products Corporation is recalling its Neonatal IV Access Sets. The recall is due to a PVP Prep Pad included in the Convenience Kit that does not meet the iodine assay level required to support the 36-month shelf life.
The affected product is identified by code IV4690 and includes specific lot codes ranging from 2015111690 to 2017080790. The recall is distributed nationally.
Healthcare facilities and suppliers should stop using the affected lots and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- NEONATAL IV ACCESS SET
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Access
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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