Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical is recalling CVC bundles 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 separation, which poses a risk of harm (infection or contamination) even though no specific injuries are reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC BUNDLE WITHOUT CATH CVI4600 kits. The recall involves 181,965 units that were distributed nationwide. The kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer.
The recall is necessary because the BD MaxZeroNeedleess Connector has a potential for droplets of fluid to separate from the sealed surface following disconnection. This defect was identified by the connector's manufacturer, BD.
Healthcare facilities and consumers who have these specific CVC bundles should stop using them and contact Centurion Medical Products Corporation for further instructions on return or replacement.
The recalled product
- Product
- CVC BUNDLE WITHOUT CATH CVI4600
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 181,965
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)
- 2019022550 2019032250
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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