Centurion Medical MINI PLASTICS SET Recalled for Iodine Assay Deficiency
Centurion Medical Products Corporation is recalling MINI PLASTICS SET kits because a 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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality control issue regarding shelf-life stability rather than an immediate acute safety risk, fitting the criteria for a moderate severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling the MINI PLASTICS SET. 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 products were distributed nationally. Specific lot codes for the recalled items include 2015102790, 2016011590, 2016030790, 2016050490, 2016062390, 2016071590, 2016081790, 2016111890, 2017012090, 2017020790, and 2017042090.
Healthcare providers and suppliers should stop using the affected MINI PLASTICS SET kits and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- MINI PLASTICS SET
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
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.
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