Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical is recalling CVC Bundle VanTex 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. The hazard involves a risk of harm (fluid droplets) from a medical device, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC Bundle VanTex 7F, 3L, 20CM kits (ECVC6065). The recall involves 181,965 units that were distributed nationwide. The kits include the BD MaxZeroNeedleess Connector, which was recalled by its manufacturer due to a potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The affected lots are identified by the following codes: 2018082450, 2018091850, 2018121850, 2018122150, 2019011550, 2019012450, and 2019013050. The source text does not specify the exact dates of distribution or the specific facilities where the products were used.
Healthcare providers and consumers should check their inventory for the specific lot codes listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions. The source text does not provide specific contact information for the recall.
The recalled product
- Product
- CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
- 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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