The Recall Desk
ModerateFDA (Devices)·Z-1078-2018·Announced 2018-03-28

Centurion Medical Products Recalls Skin Staple Remover Convenience Kits

Centurion Medical Products is recalling Skin Staple Remover Convenience Kits because the included PVP Prep Pad does not meet required iodine levels for its stated 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 Skin Staple Remover Convenience Kits. The recall is due to a quality issue where the PVP Prep Pad included in the kit does not meet the iodine assay level required to support the 36-month shelf life.

The affected products were distributed nationally. The recall includes items with the following lot codes: 2015083101, 2016101701, 2017082801, 2017030601, and 2016072501. The agency has classified this recall as Class II.

Healthcare providers and consumers should stop using the affected Convenience Kits and contact Centurion Medical Products Corporation for further instructions or a return.

The recalled product

Product
SKIN STAPLE REMOVER

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 44105 Lot codes: 2015083101 2016101701 2017082801 2017030601 2016072501

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 →