Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical is recalling CVC Bundle Multimeds containing a recalled BD connector due to potential fluid droplet separation.
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 droplet separation, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC Bundle Multimeds, 3L, 20CM (ECVC6060). The recall involves 181,965 units that were distributed nationwide.
The recall is necessary because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The BD connector has a potential for droplets of fluid to separate from the sealed surface following disconnection.
Healthcare providers and facilities should stop using the affected CVC bundles and contact Centurion Medical for further instructions.
The recalled product
- Product
- CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- 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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