Centurion Medical Products Recalls Central Line Bundles with Defective Connectors
Centurion Medical Products is recalling 181,965 central line bundles nationwide because they include a connector that 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 involves a medical device with a defect that poses a risk of harm (fluid leakage) but the source text does not report any injuries or illnesses, 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 181,965 units of CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A. These 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 due to a defect.
The defect involves the potential for droplets of fluid to separate from the sealed surface of the connector following disconnection. This issue was identified by the manufacturer of the connector component. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected central line bundles immediately. The specific code for the affected product is 2019041050. Users should contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Central Line
- 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)
- 2019041050
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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