Centurion IV Securement Kit Recall Due to Fluid Droplet Risk
Centurion Medical Products is recalling IV Securement Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a risk of harm (fluid droplets) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Centurion Medical Products Corporation is recalling 181,965 units of the IV Securement Kit (IVS3405). The recall is necessary because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The hazard involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The affected products were distributed nationwide. The recall covers specific lot codes including 2019031490, 2017100690, 2017110790, 2018011790, 2018050490, 2018060590, 2018072490, 2018110190, 2019011490, and 2019020690. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- IV SECUREMENT KIT IVS3405
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — IV Securement
- Affected units
- 181,965
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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 33 products in this recall →Related recalls
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Same hazard · fluid droplets
See all →- HighCenturion Medical Recalls Neonatal Cap Change Kits Due to Fluid Droplet Risk
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