Centurion Medical Recalls VANTEX CVC Bundles Due to Connector Defect
Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak 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 leakage) from a medical device where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling 181,965 units of VANTEX 7FR, 16CM, 3L CVC Bundles (ECVC6670). These medical device kits were distributed nationwide in the United States.
The recall is being conducted because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The affected lots are identified by the codes 2018111950, 2019031350, and 2019040550. The U.S. Food and Drug Administration has classified this as a Class II recall. Healthcare providers and facilities should stop using these specific bundles and follow the instructions provided by the recalling firm for return or disposal.
The recalled product
- Product
- VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
- 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)
- 2018111950 2019031350 2019040550
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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