Centurion Triple Lumen Bundle Kit Recalled for Fluid Droplet Risk
Centurion Medical Products is recalling Triple Lumen Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
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 and involves a medical device defect (fluid droplets) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling the TRIPLE LUMEN BUNDLE KIT ECVC1540. The recall involves 181,965 units that were distributed nationwide. The kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer due to a specific defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue is associated with the specific connector component included in the bundle kits.
Healthcare facilities and consumers who have these kits should stop using them and contact Centurion Medical Products Corporation for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRIPLE LUMEN BUNDLE KIT ECVC1540
- 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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