Centurion Medical Tubing Change Kit Recalled for Iodine Assay Failure
Centurion Medical Products Corporation is recalling Tubing Change Kits because a PVP Prep Pad component 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 defect is a chemical assay failure affecting shelf life rather than an immediate structural or biological hazard.
Plain-English summary
Centurion Medical Products Corporation is recalling Tubing Change Kits distributed nationally. 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 are identified by lot codes 2015110290, 2016090890, and 2017042690. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these products.
Consumers and healthcare facilities should stop using the affected Tubing Change Kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- TUBING CHANGE KIT
- Manufacturer
- Centurion Medical Products Corporation
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)
- DT6870 Lot codes: 2015110290 2016090890 2017042690
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.
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