Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical Products 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 exposure (risk-of-harm product) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC BUNDLE, 20CM, 3L, PI (ECVC5120) kits. The recall involves 181,965 units that were distributed nationwide in the United States. The affected lots are identified by codes 2018030150 and 2018071350.
The recall is necessary because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The specific hazard is the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
Healthcare facilities and consumers should stop using the affected CVC bundles immediately. Users should contact Centurion Medical Products Corporation for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- CVC BUNDLE, 20CM, 3L, PI ECVC5120
- 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)
- 2018030150 2018071350
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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