Centurion Medical Recalls Suture Removal Kits with Low Iodine Prep Pads
Centurion Medical Products is recalling suture removal kits because the included PVP prep pads do not meet required iodine levels for their 36-month 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 an FDA Class II recall involving a deviation from required iodine assay levels. The rubric classifies minor labeling or low-risk contamination issues, where no injuries are reported, as Moderate.
Plain-English summary
Centurion Medical Products Corporation is recalling Suture Removal Tray, Set or Kit products. The recall is due to a quality issue where the PVP Prep Pad included in the kits does not meet the iodine assay level required to support the stated 36-month shelf life.
The affected products were distributed nationally. The recall covers specific lot codes and product codes listed in the agency's documentation. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare facilities should check their inventory for the affected lot codes and stop using these kits. They should contact Centurion Medical Products Corporation for instructions on returning the products or obtaining replacements.
The recalled product
- Product
- SUTURE REMOVAL TRAY, SET or KIT
- 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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