The Recall Desk
ModerateFDA (Devices)·Z-1083-2018·Announced 2018-03-28

Centurion Medical Products Recalls Catheter Securement System Convenience Kits

Centurion Medical Products is recalling specific lots of Catheter Securement System Convenience Kits because the PVP Prep Pad does not meet required iodine levels.

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 requirements, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Centurion Medical Products Corporation is recalling specific lots of the Catheter Securement System Convenience Kit. The recall involves kits containing a PVP Prep Pad that does not meet the iodine assay level required to support the 36-month shelf life.

The affected products are identified by the code CSS490 and lot codes 2016022290 and 2017071790. The recall is distributed nationally. The source text does not specify the number of units affected or report any illnesses or injuries associated with the product.

Consumers and healthcare facilities should check their inventory for the specific lot codes listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer according to standard recall procedures.

The recalled product

Product
CATHETER SECUREMENT SYSTEM

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)

  • CSS490 Lot codes: 2016022290 2017071790

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 →