Centurion Medical Products Recalls OR VANTEX Kits Due to Connector Defect
Centurion Medical Products is recalling OR VANTEX kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate 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 involves a medical device defect that poses a risk of harm (fluid separation) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling OR VANTEX 7FR 3L 16CM CVC kits (ECVC6665). 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 defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- OR VANTEX 7FR 3L 16CM CVC ECVC6665
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Catheter Kits
- 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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