Centurion CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical Products is recalling CVC bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.
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 involves a medical device with a potential for fluid exposure (risk-of-harm product) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC BUNDLE, 20CM, 3L, PI ECVC5120A kits. The recall involves 181,965 units that were distributed nationwide. These kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer.
The recall is being conducted because of the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This defect is associated with the specific connector component included in the kits.
Healthcare facilities and consumers who have these specific CVC bundles should stop using them and contact Centurion Medical Products Corporation for instructions on how to return or dispose of the product.
The recalled product
- Product
- CVC BUNDLE, 20CM, 3L, PI ECVC5120A
- Manufacturer
- Centurion Medical Products Corporation
- 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.
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