Centurion Medical Recalls St. Christopher's Securement Sets Due to Iodine Levels
Centurion Medical Products Corporation is recalling St. Christopher's Securement Sets because the PVP Prep Pad does not meet required iodine assay 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 hospitalizations or injuries. The hazard is a quality control issue regarding shelf-life support, which aligns with the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity score.
Plain-English summary
Centurion Medical Products Corporation is voluntarily recalling the St. Christopher's Securement 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. The recall includes specific lot codes ranging from 2015080390 to 2017081890. The source text does not specify the total number of units recalled or the specific facilities affected.
Consumers and healthcare providers should stop using the affected products and contact Centurion Medical Products Corporation for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ST. CHRISTOPHER'S SECUREMENT SET
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Prep
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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