Centurion Medical Recalls Central Venous Access Device Bundles
Centurion Medical Products Corporation is recalling Central Venous Access Device Bundles because they include a connector recalled for potential fluid droplet separation.
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 defect that poses a risk of harm (fluid separation) but the source text does not report any illnesses or 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 Central Venous Access Device Bundle ECVC2840 units. The recall involves 181,965 total units that were distributed nationwide domestically.
The recall is necessary because the kits include the BD MaxZeroNeedleess Connector. This specific component was recalled by its manufacturer due to the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- 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.
See all 33 products in this recall →Related recalls
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