Centurion Minor Dressing Change Tray Recalled for Iodine Assay Failure
Centurion Medical Products is recalling Minor Dressing Change Trays because a PVP Prep Pad component failed to 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 describes a specification failure (iodine assay level) without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the Minor Dressing Change Tray (Code DT875) due to a quality control issue. The recall affects specific lots of the product distributed nationally.
The recall was initiated because a PVP Prep Pad included in the Convenience Kit was found to not meet the iodine assay level required to support the stated 36-month shelf life. This deviation from specifications may impact the product's intended performance or stability over time.
Healthcare providers and facilities should check their inventory for the affected lot codes listed in the recall notice. If the product is found, it should be removed from use and returned to Centurion Medical Products Corporation according to their instructions.
The recalled product
- Product
- MINOR DRESSING CHANGE TRAY
- Manufacturer
- Centurion Medical Products Corporation
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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