Centurion Infant IV Securement Kit Recalled by FDA
Centurion Medical Products Corporation is recalling Infant IV Securement Kits due to a Class II FDA recall. The kits are used to assist with IV placement and securement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of temporary or medically reversible health consequences.
Plain-English summary
Centurion Medical Products Corporation is recalling Infant IV Securement Kits under FDA recall number Z-1094-2018. The product is a convenience kit containing components designed to assist practitioners with IV placement and securement. The recall is classified as Class II by the FDA.
The affected products are identified by the code IVS1410 and include lot codes 2015120790, 2016040490, 2016092690, and 2017031390. The source text does not specify the exact nature of the defect or the specific health hazard associated with this recall, nor does it provide details on the distribution scope beyond the product description.
Healthcare providers and consumers should check their inventory for the specific lot codes listed above. If you have this product, you should stop using it and contact the manufacturer or the FDA for further instructions on how to return or dispose of the items.
The recalled product
- Product
- INFANT IV SECUREMENT KIT
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Securement
- Hazard
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)
- IVS1410 Lot codes: 2015120790 2016040490 2016092690 2017031390
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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