The Recall Desk
ModerateFDA (Devices)·Z-1080-2018·Announced 2018-03-28

Centurion Medical Products Recalls General Purpose Instrument Trays

Centurion Medical Products is recalling General Purpose Instrument Trays because a PVP Prep Pad in the kit does not 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 or injuries, and the hazard is a shelf-life/assay issue rather than a direct acute safety risk like a structural defect or contamination.

Plain-English summary

Centurion Medical Products Corporation is recalling General Purpose Instrument Trays. 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 and catalog numbers 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 trays and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
GENERAL PURPOSE INSTRUMENT TRAY

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 →