Centurion CVC Insertion Bundle Recalled for Fluid Droplet Risk
Centurion Medical Products is recalling CVC Insertion Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves a risk of harm (fluid droplets) from a medical device where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC Insertion Bundles (8.5FR 4L 16CM, model ECVC6355) due to a defect in the BD MaxZeroNeedleess Connector included in the kits. The manufacturer of the connector identified a potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The recall involves 181,965 units that were distributed nationwide. The affected lots are identified by the following codes: 2018030250, 2018072750, 2018090450, 2018091750, 2018122650, 2019011050, 2019020450, 2019031350, and 2019040150.
Healthcare providers and consumers should stop using the affected CVC Insertion Bundles and contact Centurion Medical Products Corporation for further instructions on the recall.
The recalled product
- Product
- CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
- 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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