Centurion Medical Incision and Drainage Kits Recalled for Iodine Deficiency
Centurion Medical Products is recalling Incision & Drainage Kits because a PVP Prep Pad failed to meet required iodine levels for shelf life.
What this means for you
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, injuries, or illnesses. The hazard is a failure to meet shelf-life specifications, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Centurion Medical Products Corporation is recalling Incision & Drainage Trays or Kits. The recall is due to a PVP Prep Pad included in the kits that does not meet the iodine assay level required to support the stated 36-month shelf life.
The affected products were distributed nationally. The recall includes specific lot codes and product codes listed in the agency's documentation. No illnesses or injuries have been reported in the source text.
Healthcare facilities and suppliers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions on returns or replacements.
The recalled product
- Product
- INCISION & DRAINAGE TRAY 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.
See all 21 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · shelf life deficiency
See all →- ModerateEthicon Recalls Silk Sutures Due to Potential Shelf Life Deficiency
FDA (Devices) · 2020-07-08
- ModerateCenturion SorbaView Shield Dressing Change Tray Recalled for Iodine Level Deficiency
FDA (Devices) · 2018-03-28
- ModerateCenturion Medical Products Recalls Skin Staple Remover Convenience Kits
FDA (Devices) · 2018-03-28