The Recall Desk
ModerateFDA (Devices)·Z-1089-2018·Announced 2018-03-28

Centurion Medical Blood Draw Kit Recalled for Iodine Assay Deficiency

Centurion Medical Products Corporation is recalling Blood Draw Kits because the PVP Prep Pad 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 describes a shelf-life/assay issue without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Centurion Medical Products Corporation is recalling Blood Draw Kits distributed nationally. The recall involves specific lot codes: 2016032890, 2016091290, and 2016112890.

The recall was initiated because the Convenience Kit contains a PVP Prep Pad that does not meet the iodine assay level required to support the 36-month shelf life. This is a Class II recall, indicating a situation that could temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and suppliers should stop using the affected kits and contact the recalling firm for further instructions.

The recalled product

Product
BLOOD DRAW KIT

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)

  • IV4285 Lot codes: 2016032890 2016091290 2016112890

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 →