Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk
Centurion Medical Products is recalling CVC 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 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 for theoretical risks.
Plain-English summary
Centurion Medical Products Corporation is recalling CVC Bundles (20CM, 4L, PI ECVC5095) due to a defect in the included BD MaxZeroNeedleess Connector. The recall involves 181,965 units that were distributed nationwide.
The recall was initiated because the connector has the potential for droplets of fluid to separate from the sealed surface following disconnection. This issue was originally identified by the manufacturer of the connector, BD.
Healthcare facilities and consumers should stop using the affected CVC Bundles and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- CVC BUNDLE, 20CM, 4L, PI ECVC5095
- 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)
- 2018031450 2018040950 2018050750 2018053150 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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