Centurion Medical Products Recalls Central Line Bundles with Defective Connectors
Centurion Medical Products is recalling Central Line Bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the sealed surface.
What this means for you
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 separation) in a medical device where no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling Central Line Bundles (ECVC6375) that include the BD MaxZeroNeedleess Connector. The recall was initiated because the connector was recalled by its manufacturer due to a potential for droplets of fluid to separate from the sealed surface following disconnection.
A total of 181,965 units were distributed nationwide. The affected lots are identified by the codes 2018091150, 2018101050, 2018121950, and 2019010950. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should stop using the affected Central Line Bundles and contact Centurion Medical Products Corporation for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- CENTRAL LINE BUNDLE ECVC6375
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Central Line
- Hazard
- 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)
- 2018091150 2018101050 2018121950 2019010950
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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